[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-pancreatic-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-pancreatic-cancer":689},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,34,0,25,[9,52,84,105,137,164,190,209,239,264,287,317,342,370,395,420,448,477,537,556,577,598,623,645,669],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100379579",false,"NCT04222413","Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors","First-in-Human Phase I Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors","* INCLUSION CRITERIA:\n* Adult (\\>= 18 years) subjects with:\n\n  * histologically or cytologically confirmed solid tumors (Phase IA).\n\nOR\n\n--histologically or cytologically confirmed pancreatic, colorectal, or breast cancer (Phase IB)\n\nOR\n\n* Pediatric (\\>=12 and \\\u003C 18 years) subjects with histologically or cytologically confirmed solid tumors other than rhabdomyosarcoma (RMS) including embryonal, alveolar, spindle cell\u002Fsclerosing and pleomorphic subtypes of RMS (Phase IB).\n* Subjects must have disease that:\n\n  * is not amenable to potentially curative resection,\n  * spread at least to one other organ system other than primary tumor or recurred after removal of primary tumor\n  * has site measurable per RECIST 1.1\n  * progressed on or after at least one line of standard systemic chemotherapy (Phase IA and IB1)\n  * have no standard therapy option available (Phase IB2)\n* Patients must have recovered from any acute toxicity related to prior therapy or surgery or disease to a grade 1 or less.\n* Performance status\n\n  --Karnofsky \\>= 70% (for patients \\>= 16 years old), Lansky \\>= 70% (for patients \\\u003C16 years old)\n* Adequate hematological function defined by:\n\n  * absolute neutrophil count (ANC) \\>= 1.0 x 10(9)\u002FL,\n  * transfusion-independent platelet count \\>= 100 x 10(9)\u002FL,\n  * Hgb \\>= 9 g\u002F dL (patients who have received \\\u003C= 2 PRBC transfusions within 48 hours are eligible)\n* Adequate coagulation as defined by:\n\n  --INR\\\u003C1.5 (or \\\u003C 3.0 if subjects are currently taking anticoagulated medications) Note: increase of the upper limit of INR is restricted only to subjects who are receiving anticoagulation for medical reasons (DVT\u002FPE prophylaxis, treatment for a thromboembolic event) and have increased INR because of these medications. Patients who have an elevated INR due to compromised liver function or any other medical conditions remain excluded\n* Adequate hepatic function defined by:\n\n  * a total bilirubin level \\\u003C= 1.5 x ULN, (total bilirubin \\\u003C= 2.0 x ULN in case of prior diagnosis of Gilbert syndrome)\n  * an AST level \\\u003C= 3xULN\n  * an ALT level \\\u003C= 3 xULN\n* Adequate renal function defined by:\n\n  * Creatinine OR Measured or calculated creatinine clearance (CrCl) (eGFR may also be used in place of CrCl)\n\n    ---\\\u003C 1.5x institution upper limit of normal OR\n\n    ---\\>= 45 mL\u002Fmin\u002F1.73 m\\^2 for participant with creatinine levels \\>= 1.5 X institutional ULN\n  * Creatinine clearance (CrCl) or eGFR should be calculated per institutional standard.\n* The effects of the study treatment on the developing human fetus are unknown; thus, individuals of childbearing potential and individuals who can father children must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior\n\nto study entry, for the duration of study therapy and up to 120 days after the last dose of the study drug.\n\n* Nursing participants must be willing to discontinue nursing at the time of the study treatment initiation.\n* Weight \\>= 35 kg.\n* Ability of subject or parent\u002Fguardian to understand and the willingness to sign a written informed consent document.\n* Subjects must have lesion(s) accessible for biopsy (other than used for measurement of disease) and be willing to undergo mandatory study biopsies (Cohort IB1 only).\n* Ability to swallow oral capsules.\n\nEXCLUSION CRITERIA:\n\n* Anticancer treatment within designated period before treatment initiation including:\n\n  * minor surgical procedure (such as biliary stenting) within 14 days. Note: if liver function tests after biliary stenting or renal function tests after ureteral stenting return to normal, within 5 days after biliary or ureteral stenting;\n  * major surgical procedure or curative radiation treatment within 28 days;\n  * palliative radiation treatment within 14 days;\n  * chemotherapy or experimental drug treatment with published half-life known to be 72 hours or less within 14 days;\n  * experimental drug treatment with unpublished or half-life greater than 72 hours within 28 days;\n  * chemotherapy regimen containing an alkylating antineoplastic agent (cyclophosphamide, chlorambucil, melphalan, or ifosfamide), alkylating-like (platinumbased chemotherapeutic drugs, platinum analogues), and non-classical alkylating agent (dacarbazine, temozolomide) within 28 days.\n* Patients receiving any medications or substances that are moderate and strong inhibitors or inducers of CYP3A4 and are not able to safely stop these medications are excluded from this study; patients must stop strong CYP3A4 inhibiting\u002Finducing medications within 5 published half-lives and moderate within 3 published half-lives prior to the treatment initiation.\n\nNote: dihydropyridine calcium - channel blockers are permitted for management of underling disease\n\n* Subjects with cardiomyopathy diagnosed within 6 months prior to treatment initiation including but not limited to the following:\n\n  * hypertrophic cardiomyopathy\n  * arrhythmogenic right ventricular cardiomyopathy\n  * abnormal ejection fraction (echocardiogram \\[ECHO\\]) \\\u003C= 53% (if a range is given then the upper value of the range will be used)\n  * previous moderate or severe impairment of left ventricular systolic function (LVEF \\\u003C45%)\n  * severe valvular heart disease\n  * atrial fibrillation with a ventricular rate \\>100 bpm on EKG at rest\n  * Fridericia's corrected QT interval (QTcF) \\>= 480 msec (adults) or \\>= 460 msec (pediatric subjects, aged 12 to \\\u003C18 years) or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome.\n* HIV, HCV, HBV positive patients on antiviral drugs are excluded due to the absence of previous experience with concurrent use of antiviral medications and the investigational drug product to be evaluated in the current study and possible for adverse pharmacokinetic and\u002For pharmacodynamic interactions.\n* Previous malignant disease (other than the target malignancy to be investigated in this trial) within the last 3 years. Note: subjects with a history of cervical carcinoma in situ, superficial or non-invasive bladder cancer, or basal cell or squamous cell carcinoma in situ previously treated with curative intent are NOT excluded.\n* Rapidly progressive disease which, in the opinion of the Investigator, may predispose to inability to tolerate treatment or trial procedures.\n* Subjects with central nervous system (CNS) metastases or CNS disorders known to increase possible neurotoxicity of metarrestin in case of compromised blood-brain barrier (e.g. recent stroke (\\\u003C3 months of treatment initiation), infectious causes).\n* Significant acute or chronic infections including tuberculosis with presence of clinical symptoms or physical findings.\n* Patients with a history of any seizures or increased risk of seizures on screening EEGs defined by 1) interictal epileptiform discharges, 2) temporal intermittent rhythmic delta activity (TIRDA), or 3) electrographic or clinical seizures on EEG.\n* Clinically relevant diseases (for example, inflammatory bowel disease) and \u002F or uncontrolled medical conditions, which, in the opinion of the Investigator, might impair the subject's tolerance or ability to participate in the trial.\n* Patients with previous gastric bypass, patients receiving nutrition via feeding tubes or parenterally, or patients with malabsorptive conditions (damage to the intestine from infection, inflammation, trauma, or surgery, celiac disease, Crohn's disease, chronic pancreatitis, or cystic fibrosis resulting malabsorption). Patients with refractory nausea and vomiting. Note: patients with gastric banding are allowed.\n* Pregnant individuals.","ALL","12 Years","120 Years",{"count":20,"type":21},116,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","Background:\n\nMetastasis is the spread of cancer from one organ to a nonadjacent organ. It causes 90% of cancer deaths. No treatment specifically prevents or reduces metastasis. Researchers hope a new drug can help. It stops cancer cells from growing and spreading further and possibly shrink cancer lesions in distant organs.\n\nObjective:\n\nTo find a safe dose of metarrestin and to see if this dose shrinks tumors.\n\nEligibility:\n\nAdults age 18 and older with pancreatic cancer, breast cancer, or a solid tumor that has not been cured by standard therapies. Also, children age 12-17 with a solid tumor (other than a muscle tumor) with no standard therapy options.\n\nDesign:\n\nParticipants will be screened with:\n\n* blood tests\n* physical exam\n* documentation of disease confirmation or tumor biopsy\n* electrocardiogram to evaluate the heart\n* review of their medicines and their ability to do their normal activities\n\nParticipants will take metarrestin by mouth until they cannot tolerate it or stop to benefit from it. They will keep a medicine diary.\n\nParticipants will visit the Clinical Center. During the first month there are two brief hospital stays required with visits weekly or every other week thereafter. They will repeat some of the screening tests. They will fill out questionnaires. They will have tests of their cognitive function. They will have an electroencephalogram to record brain activity. They will have a computed tomography (CT) scan or magnetic resonance imaging (MRI). A CT is a series of X-rays of the body. An MRI uses magnets and radio waves to take pictures of the body.\n\nAdult participants may have tumor biopsies.\n\nParticipants will have a follow-up visit 30 days after treatment ends. Then they will have follow-up phone calls or emails every 6 months for the rest of their life or until the study ends.\n\n...",[27,28,29,30,31,32],"Advanced Solid Tumors","Metastatic Pancreatic Cancer","Pediatric Solid Tumor","Advanced Breast Cancer","Malignant Peripheral Nerve Sheath Tumor","Colorectal Neoplasms",[34,35,36,37,38],"First-In-Class Investigational Agent","Peri-Nucleolar Compartment (PNC)","effective therapies against metastasis","Oral Administration","Maximum Recommended Starting Dose","RECRUITING","2026-07-01",{"date":42,"type":43},"2026-07-02","ACTUAL",{"date":45,"type":43},"2020-10-27",{"date":47,"type":21},"2028-12-31",{"name":49,"class":50},"National Cancer Institute (NCI)","NIH",2,{"id":53,"slug":4,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":5},"100624410","NCT07409272","A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer","A Phase 3, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of ASP3082 in Combination With mFOLFIRINOX or NALIRIFOX as First-line Treatment in Participants With KRAS G12D Mutated Metastatic Pancreatic Adenocarcinoma","Inclusion Criteria:\n\n* Participant has histologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC) with documented Kirsten rat sarcoma viral oncogene homolog (KRAS) G12D mutation based on local or central testing (confirmation of a participant's positive KRAS G12D mutation result must be available prior to randomization).\n* Participant has no option for surgical resection or radiotherapy with curative intent.\n* Participant consents to and provides a baseline tumor tissue specimen for the study during screening. The sample must meet the requirements described in the laboratory manual and the tumor sample guidance.\n* Participant has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 within 7 days prior to randomization.\n* Participant has adequate organ function as indicated by the following laboratory values within 7 days prior to randomization (if a participant has received a recent blood transfusion, the latest laboratory tests must be obtained ≥ 14 days after any blood transfusion). The laboratory values prior to the initiation of the first dose of setidegrasib\u002Fplacebo (or mFOLFIRINOX\u002FNALIRIFOX, if chemotherapy is administered during the screening period) should be used to determine eligibility. Participants who receive mFOLFIRINOX\u002FNALIRIFOX during the screening period must meet these criteria within 7 days prior to the start of on-treatment chemotherapy (i.e., C1D1).\n* Participant agrees not to participate in another interventional study while receiving study intervention in the present study (participant who is currently in the follow-up period of an interventional clinical trial is allowed).\n\nExclusion Criteria:\n\n* Participant has neuroendocrine, acinar pancreatic carcinoma or pancreatic cancer with squamous\u002Fadenosquamous features.\n* Participant has another prior malignancy active (i.e., requiring treatment, including hormonal therapies, or intervention) within the previous 2 years different from the primary malignancy for this study, except for local malignancies that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast, which are allowed.\n* Participant has chronic inflammatory bowel disease, bowel obstruction and\u002For severe uncontrolled diarrhea.\n* Participant has peripheral sensory neuropathy with functional impairment.\n* Participant has ascites and\u002For pleural effusion that require invasive interventions within 30 days prior to randomization or have an indwelling drainage catheter.\n* Participant has symptomatic pulmonary embolism or pulmonary embolism not being treated with anticoagulation.\n* Participant has a history of interstitial lung disease or pulmonary fibrosis.\n* Participant has uncontrolled seizure disorder or refractory to antiepileptics.\n* Participant has known homozygous uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) polymorphism.\n* Participant has had a myocardial infarction, unstable angina or coronary artery bypass surgery within 6 months prior to randomization or currently has an uncontrolled illness including but not limited to symptomatic congestive heart failure, clinically significant cardiac disease (e.g., cardiomyopathy, infiltrative cardiac disease, etc.), unstable angina pectoris, cardiac arrhythmia, obligate use of a cardiac pacemaker or long QT interval (QT) syndrome.\n* Participant has received any prior systemic therapy for their metastatic PDAC (except with up to 2 doses \\[i.e., 28 days; 1 cycle\\] of mFOLFIRINOX or NALIRIFOX during the screening period. If a participant received \\[neo\\]adjuvant chemotherapy, tumor recurrence or disease progression must have occurred ≥ 6 months after completing the last dose of the \\[neo\\]adjuvant therapy).\n* Participant has had prior treatment with a KRAS G12D-targeted agent.\n* Participant has a corrected QT interval by Fridericia (QTcF) (single electrocardiogram \\[ECG\\]) \\> 470 msec during the screening period.","18 Years",{"count":60,"type":21},614,[62],"PHASE3","Pancreatic cancer is difficult to diagnose early. By the time people have been diagnosed, the cancer has usually spread to other parts of the body (metastatic). The standard treatment is chemotherapy, but other treatments are needed to improve outcomes in people with pancreatic cancer. The first treatment that people usually receive is chemotherapy. At the time this study started, some of the main standard chemotherapies for pancreatic cancer were mFOLFIRINOX or NALIRIFOX.\n\nGenes give your body instructions on how to make proteins. Proteins are needed to keep the body working properly. Many types of cancer are caused by changes in certain genes, making them faulty. Many people with pancreatic cancer have a faulty KRAS gene. One such change in the KRAS gene is called a G12D mutation. Researchers are looking for ways to stop the actions of abnormal proteins made from the KRAS G12D mutation.\n\nThis study is about setidegrasib given with chemotherapy in people with pancreatic cancer who have the KRAS G12D mutation. Before setidegrasib can become an approved treatment, clinical studies need to be completed to understand how it works and how safe it is.\n\nThe main aim is to learn if people who are given setidegrasib with chemotherapy live for longer than people who are given placebo with chemotherapy. Other aims are to learn if setidegrasib delays the cancer and symptoms returning, how the body processes setidegrasib, and its safety, when given with chemotherapy.\n\nPeople in this study will be adults with metastatic pancreatic cancer with the G12D mutation in their KRAS gene. Surgery or radiotherapy will not be an option to cure their cancer.\n\nPeople cannot take part if the cancer cells have spread to the thin tissue covering the brain and spinal cord (leptomeningeal disease), have symptoms of cancer in the brain or nervous system, or have recently had some other cancers that required treatment.\n\nIn this study, people are given either setidegrasib with mFOLFIRINOX or NALIRIFOX chemotherapy, or a placebo with mFOLFIRINOX or NALIRIFOX chemotherapy. Whether people receive setidegrasib or placebo is decided by chance. The study doctor decides which chemotherapy (mFOLFIRINOX or NALIRIFOX) people receive. People will only receive NALIRIFOX chemotherapy (with setidegrasib or placebo) after the safety of setidegrasib with NALIRIFOX chemotherapy has been confirmed in another ongoing setidegrasib study. All of the study treatments are given slowly through a tube into a vein (infusion). People will continue to receive study treatment until their cancer gets worse, they can't tolerate the study treatment, they start other cancer treatment, they or the doctor decides the person should stop receiving study treatment, or sadly they pass away. There will be safety checks at each visit, and the doctors will continue to check for medical problems and people's wellbeing throughout the study.",[65,28,66],"Pancreatic Cancer","Metastatic Pancreatic Adenocarcinoma",[65,28,66,68,69,70,71,72,73],"ASP3082","setidegrasib","KRAS G12D","PDAC","mFOLFIRINOX","NALIRIFOX","2026-06-24",{"date":76,"type":43},"2026-06-25",{"date":78,"type":43},"2026-02-17",{"date":80,"type":21},"2029-08-31",{"name":82,"class":83},"Astellas Pharma Global Development, Inc.","INDUSTRY",{"id":85,"slug":4,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"100613129","NCT07262567","Phase III Study to Compare GFH375 and Chemotherapy in Patients With KRAS G12D-Mutant Metastatic Pancreatic Cancer","A Multicenter, Open-Label, Randomized Controlled Phase III Study to Compare the Efficacy and Safety\u002FTolerability of GFH375 Monotherapy Versus Investigator's Choice of Chemotherapy in Patients With Previously Treated KRAS G12D-Mutant Metastatic Pancreatic Cancer","Inclusion Criteria:\n\n* Voluntarily participate in the study and sign the informed consent form.\n* Male or female aged 18-80 years (inclusive) at the time of signing the informed consent form.\n* Pathologically confirmed pancreatic cancer (derived from pancreatic ductal epithelium) at metastatic stage.\n* Have received at least one prior standard systemic therapy.\n* Participants must have at least one measurable lesion (per RECIST 1.1 criteria).\n* Expected survival time ≥ 12 weeks as judged by the investigator.\n* Have adequate organ function\n\nExclusion Criteria:\n\n* Other malignant tumors that progressed or required treatment within 3 years prior to randomization.\n* With active central nervous system (CNS) metastasis.\n* Previous receipt of therapy targeted for KRAS G12D or pan-RAS\u002FKRAS.\n* Received radiotherapy within 4 weeks prior to randomization or other local anti-tumor therapy within 4 weeks prior to randomization.\n* Received other anti-tumor therapy within 28 days or 5 half-lives (whichever is shorter) prior to randomization.\n* With clinically significant severe cardiovascular diseases.\n* Stroke or other severe cerebrovascular diseases within 6 months prior to randomization.\n* Complicated with major acute or chronic infectious diseases.\n* Have severe mental or psychological diseases, or a history of drug abuse or severe alcoholism.\n* Pregnant or lactating females.\n* Other conditions deemed inappropriate for participation in the study by the investigator.","80 Years",{"count":92,"type":21},320,[62],"This study plans to enroll participants with previously treated metastatic pancreatic cancer and harbor centrally confirmed KRAS G12D mutation. These participants are required to experience disease progression on or after at least one prior standard systemic therapy containing fluorouracil or gemcitabine, and either progressed on or were intolerant to the last treatment. Eligible participants will be randomized 1:1 to the experimental group or the control group for treatment.",[28],{"date":97,"type":43},"2026-06-26",{"date":99,"type":43},"2025-12-04",{"date":101,"type":21},"2028-06",{"name":103,"class":83},"Genfleet Therapeutics (Shanghai) Inc.",1,{"id":106,"slug":4,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":117,"conditions":118,"keywords":119,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":104},"100510703","NCT05929885","Metronomic Capecitabine, Oxaliplatin and UGT1A1 Genotype-directed Irinotecan in Metastatic Pancreatic Cancer Patients","A Phase II Study of Metronomic Capecitabine, Oxaliplatin and UGT1A1 Genotype-directed Irinotecan in Metastatic Pancreatic Cancer Patients.","Inclusion Criteria:\n\nThe patient must meet all of the inclusion criteria to participate in the study.\n\n1. Aged above 21\n2. Histopathological diagnosis of pancreatic cancer\n3. Advanced disease not amenable to curative resection (locally advanced or metastatic disease)\n4. Measureable disease by RECIST 1.1 criteria\n5. Life expectancy of at least 12 weeks\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n7. Adequate hematologic function (granulocyte count ≥ 1.5 × 10\\*\\*9\u002FL, platelet count ≥ 100 × 10\\*\\*9\u002FL),\n8. Adequate hepatic function (total bilirubin ≤ 1.5 x the upper limits of normal \\[ULN\\], AST and ALT, ALP ≤ 3 x ULN or \\\u003C 5 x ULN in case of hepatic involvement),\n9. Adequate renal function (creatinine clearance \\> 50 mL\u002Fmin) will be eligible for inclusion into the study.\n10. Able to provide written and informed consent\n\nExclusion Criteria:\n\nAny patient meeting any of the exclusion criteria at baseline will be excluded from participation.\n\n1. History of another malignancy within 5 years prior to registration. Patients with a past history of adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and superficial transitional cell carcinoma of the bladder are eligible. Patients with a history of other malignancies are eligible if they have been continuously disease free after definitive primary treatment for at least 5 years.\n2. Untreated CNS metastases or leptomeningeal disease. Patients with brain metastases that have been treated, and are asymptomatic, and have been stable for 3 or more months after treatment are allowed. A baseline CT or MRI brain is only required if there is clinical suspicion of CNS involvement.\n3. Concurrent illness, including severe infection, that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety\n4. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol\n5. Treatment with palliative chemotherapy or radiotherapy within 4 weeks prior to enrolment into the study\n6. Major surgery within two weeks prior to enrolment into the study\n7. Patients on chronic immunosuppressive therapy\n8. Pregnancy, lactation or inadequate contraception. Women of childbearing potential must have a negative pregnancy test within 3 days of enrolment and agree to use a reliable means of contraception. Men must have been surgically sterilised or agree to use a barrier method of contraception\n9. Patients on anticoagulant therapy with vitamin K antagonists.","21 Years","99 Years",{"count":114,"type":21},50,[116],"PHASE2","This is a single-centre, non-randomized, open label phase II trial to be conducted at the National Cancer Centre, Singapore (NCCS). Patients diagnosed with metastatic PDAC will be eligible to enrol.\n\nThe investigators hypothesize the anticancer activity of low dose OXIRI (LD-OXIRI) regimen comprising of metronomic oxaliplatin (O) and metronomic capecitabine (xeloda; X) in combination with UGT1A1-directed dosing of irinotecan (IRI) to be a tolerable regimen in patients with advanced PDAC and will lead to a favourable response rate.\n\nPatients will be prospectively enrolled in two stages - In stage 1, patients will be recruited and evaluated for response and toxicity. In stage 2, more patients will be recruited for further evaluation of response and toxicity.",[28],[120,65,121,122,123,124,125,126],"Low Dose OXIRI (LDOXIRI)","Irinotecan","Oxaliplatin","Capecitabine","Pharmacokinetics","Metronomic Chemotherapy","UGT1A1","2026-06-18",{"date":129,"type":43},"2026-06-23",{"date":131,"type":43},"2023-08-30",{"date":133,"type":21},"2027-02-28",{"name":135,"class":136},"National Cancer Centre, Singapore","OTHER",{"id":138,"slug":4,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":22,"phases":146,"briefSummary":148,"conditions":149,"keywords":152,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":104},"100465885","NCT05346536","Liquid Biopsy and Pancreas Cancer: Detection of AXL(+) CTCs (CTC-AXL-PANC)","Liquid Biopsy and Pancreas Cancer: Detection of AXL(+) Functional CTCs Using EPIDROP","CTC-AXL-PANC","Inclusion Criteria:\n\n* The patient is at least 18 years old;\n* Patients with pancreatic cancer with remote metastases, naïve of any treatment, that is, eligible for a first line of treatment;\n* Patients with oral consent\n\nExclusion Criteria:\n\n* Non-affiliation or non-beneficiary of a Social Security regimen;\n* Frailty persons according to Article L1121-6 of the CSP;\n* Adult protected or unable to give consent as per Article L1121-8 of the CPMP;\n* Pregnant or lactating women as per MSC L1121-5.\n* Not included for monitoring difficulties (mutation, insufficient motivation, predictable poor compliance, priority associated pathology in care, etc.)",{"count":145,"type":21},63,[147],"NA","In solid cancers, some more aggressive tumor cells actively detach from the primary lesion and then travel through the circulating compartment to reach distant organs and form micro-metastases. These circulating tumor cells (CTCs) that have become disseminated tumor cells (DTCs) flourish in their new environments and may remain dormant for many years after the complete resection of the primary tumor. Detecting CTCs in the blood is also relevant for assessing tumor progression, prognosis and therapeutic follow-up. The non-invasive, highly sensitive for CTCs analysis is called \"liquid biopsy\". Pancreatic adenocarcinoma and breast cancer remain among cancers of very poor prognosis and thus represent a major therapeutic challenge. In recent years, the Axl membrane tyrosine kinase receptor has been the target of growing interest. Activation of the Gas6\u002FAxl signaling pathway is associated with, among other things, tumor cell growth and survival, epithelial to mesenchymal transition (EMT) or drug resistances. In addition, Axl overexpression is frequently identified in patients with pancreatic adenocarcinoma and is associated with a poor prognosis. For example, the Laboratoire des Cellules Circulantes Rares Humaines (LCCRH) at the CHU and the University of Montpellier has developed two new \"CTC-AXL\" tests to detect CTCs expressing Axl: one using the CellSearch® (gold standard and FDA-approved) system and the other using the EPIDROP technique. The purpose of this research project is to assess the concordance of the \"CTC-AXL\" measurement by the innovative EPIDROP technique and the CellSearch® technique in patients with metastatic pancreatic or breast cancer.",[150,28,151],"Pancreatic Ductal Adenocarcinoma","Circulating Tumor Cell",[28,151,153,154],"AXL","CellSearch","2026-06-17",{"date":157,"type":43},"2026-06-22",{"date":159,"type":43},"2022-06-16",{"date":161,"type":21},"2027-12-31",{"name":163,"class":136},"University Hospital, Montpellier",{"id":165,"slug":4,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":18,"enrollmentInfo":170,"targetDuration":4,"studyType":22,"phases":172,"briefSummary":173,"conditions":174,"keywords":176,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":189},"100569762","NCT06698458","Alpha Radiation Emitters (DaRT) With Chemotherapy for the Treatment of Locally Advanced and Metastatic Pancreatic Cancer","A Study to Assess the Safety of Intratumoral Diffusing Alpha Radiation Emitters With Chemotherapy for the Treatment of Locally Advanced and Metastatic Pancreatic Cancer","Inclusion Criteria:\n\n* Histologically and\u002For cytologically proven newly diagnosed locally advanced inoperable pancreatic adenocarcinoma (Cohort 1) OR histologically and\u002For cytologically proven newly diagnosed metastatic pancreatic adenocarcinoma (Cohort 2).\n* Patients will start treatment with mFOLFIRINOX (up to 4 cycles) before DaRT insertion\n* Target lesion is technically amenable for Alpha DaRT sources implantation.\n* Measurable lesion per RECIST (version 1.1) criteria\n* Lesion size ≤ 5 cm in the longest diameter\n* Interstitial radiation indication validated by a multidisciplinary team.\n* ECOG Performance Status Scale 0 -2\n* Life expectancy is more than 6 months\n* WBC ≥ 3500\u002Fμl, granulocyte ≥ 1500\u002Fμl\n* Platelet count ≥60,000\u002Fμl\n* Creatinine ≤1.9 mg\u002FdL\n* AST and ALT ≤ 2.5 X upper limit of normal (ULN)\n* INR \\\u003C 1.4 for patients not on Warfarin\n* Age ≥18 years old\n* Subjects are willing and able to sign an informed consent form\n* Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test before the Ra-224 implantation and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after initiation of Alpha DaRT therapy.\n* Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after DaRT insertion.\n\nExclusion Criteria:\n\n* For Cohort 1 only: Borderline unresectable pancreatic cancer, and\u002For fit for surgical exploration unless patient refuses surgery.\n* For Cohort 1 and Cohort 2: Prior treatment for pancreatic cancer, including chemotherapy except for 1 - 4 cycles of mFOLFIRINOX, radiation therapy, immunotherapy, etc.\n* Known hypersensitivity to any of the components of the treatment.\n* Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.\n* Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.\n* Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial or interfere with the study endpoints.\n* Has a known additional malignancy that is progressing or requires active treatment.\n\nExceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, low risk prostate cancer, or in situ cervical cancer.\n\n* Patient requires treatment not specified in this protocol which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT.\n* Patients do not agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after DaRT insertion.\n* Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT.\n* High probability of protocol non-compliance (in opinion of investigator).\n* Breastfeeding women or women of childbearing potential unwilling or unable to use an acceptable contraceptive method to prevent pregnancy for 3 months after DaRT insertion\n* Patients who are at high risk of complications from radiation due to genetic conditions\u002Fmutations, inflammatory bowel disease, or connective tissue disease.",{"count":171,"type":21},40,[147],"This is a multi-center clinical study enrolling up to 30 participants (15 patients in each cohort). The primary objective of the study is to evaluate the safety of Alpha DaRT in combination with chemotherapy, based on the cumulative incidence rate, severity and outcome of device related AEs. Classification of AEs will be done according to CTCAE V5. The secondary objectives of the study are to:\n\n* Assess efficacy of the Alpha DaRT sources in combination with chemotherapy, determined by overall and progression-free survival.\n* Assess pain control\n* Assess rate of surgical resection in Cohort 1.",[65,175,28],"Pancreatic Adenocarcinoma",[177,178,175,179],"Alpha radiation","pancreatic cancer","Unresectable Pancreatic Cancer","2026-06-15",{"date":182,"type":43},"2026-06-16",{"date":184,"type":43},"2025-06-17",{"date":186,"type":21},"2026-12",{"name":188,"class":83},"Alpha Tau Medical LTD.",15,{"id":191,"slug":4,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":22,"phases":197,"briefSummary":198,"conditions":199,"keywords":200,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":203,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":51},"100489793","NCT05657743","Alpha Radiation Emitters Device for the Treatment of Advanced Pancreatic Cancer (Feasibility and Safety)","A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Advanced Pancreatic Cancer","Inclusion Criteria\n\n* Histologically and\u002For cytologically proven locally advanced or metastatic pancreatic adenocarcinoma\n* Patients must have i) received at least one line of chemotherapy OR ii) are medically unfit for further chemotherapy, AND iii) the tumor is still not deemed as resectable with radical surgery or the patient does not wish to go through surgery\n* Target lesion is technically amenable for at least 50% coverage by the Alpha DaRT seeds as determined by the treating physician\n* Interstitial radiation indication validated by a multidisciplinary team\n* Measurable lesion per RECIST (version 1.1) criteria\n* Lesion size ≤ 5 cm in the longest diameter\n* Age ≥18 years old\n* ECOG Performance Status Scale ≤ 2\n* Life expectancy is more than 6 months\n* WBC ≥ 3500\u002Fµl, granulocyte ≥ 1500\u002Fµl\n* Platelet count ≥60,000\u002Fµl\n* Calculated or measured creatinine clearance ≥ 60cc\u002Fmin. Calculated or measured creatinine clearance can be≥ 40cc\u002Fmin given stability of creatinine levels over the past three weeks (at least 1 test per week).\n* AST and ALT ≤ 2.5 X upper limit of normal (ULN)\n* INR \\\u003C 1.4 for patients not on Warfarin\n* Subjects are willing and able to sign an informed consent form\n* Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test before the Ra-224 implantation and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after brachytherapy.\n* Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy.\n\nExclusion Criteria:\n\n* Concomitant chemotherapy or immunotherapy within the past 4 weeks\n* Brain metastases\n* Borderline unresectable pancreatic cancer, and\u002For cases fit for surgical exploration unless patient refuses surgery\n* Known hypersensitivity to any of the components of the treatment.\n* Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.\n* Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.\n* Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial or interfere with the study endpoints.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n* Patient requires treatment not specified in this protocol which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT.\n* Patients do not agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy.\n* Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT.\n* High probability of protocol non-compliance (in opinion of investigator).\n* Breastfeeding women or women of childbearing potential unwilling or unable to use an acceptable contraceptive method to prevent pregnancy for 3 months after RT.",{"count":189,"type":21},[147],"A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for advanced pancreatic cancer",[65,179,28,175],[178,179,28,175,201,177,202],"Pancreas Neoplasm","Pancreas Metastases",{"date":182,"type":43},{"date":205,"type":43},"2023-08-16",{"date":207,"type":21},"2027-11",{"name":188,"class":83},{"id":210,"slug":4,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":215,"enrollmentInfo":216,"targetDuration":4,"studyType":22,"phases":218,"briefSummary":219,"conditions":220,"keywords":225,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":104},"100146180","NCT01174121","Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer","A Phase II Study Using Short-Term Cultured, Autologous Tumor-Infiltrating Lymphocytes Following a Lymphodepleting Regimen in Metastatic Cancers Plus the Administration of Pembrolizumab","* INCLUSION CRITERIA:\n* Measurable (per RECIST v1.0 criteria), metastatic cancer of one of the following types: upper or lower gastrointestinal, hepatobiliary, genitourinary, breast, ovarian\u002Fendometrial, or endocrine tumors including neuroendocrine tumors. Patients must have at least one lesion that is resectable for TIL generation with minimal morbidity, preferentially using minimal invasive laparoscopic or thoracoscopic surgery for removal of superficial tumor deposit.\n* Confirmation of diagnosis of metastatic cancer by the NCI Laboratory of Pathology.\n* Refractory to approved standard systemic therapy. Specifically:\n\n  * Patients with metastatic colorectal cancer must have received oxaliplatin or irinotecan.\n  * Patients with hepatocellular carcinoma must have received sorafenib (Nexavar(R)), since level 1 data support a survival benefit with this agent.\n  * Patients with breast and ovarian cancer must be refractory to both first- and second-line treatments and must have received at least one second-line chemotherapy regimen.\n* Patients with 3 or fewer brain metastases that are \\\u003C 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month after treatment for the patient to be eligible. Patients with surgically resected brain metastases are eligible.\n* Age greater than or equal to 18 years and less than or equal to 72 years.\n* Clinical performance status of ECOG 0 or 1.\n* Patients of both sexes must be willing to practice birth control from the time of enrollment on this study and 12 months after the last dose of combined chemotherapy for individuals of child-bearing potential (IOCBP) and for four months after treatment for individuals that can father children.\n* IOCBP must have a negative pregnancy test be a pregnancy test prior to the start of treatment because of the potentially dangerous effects of the treatment on the fetus.\n\nSerology\n\n* Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive may have decreased immune-competence and thus may be less responsive to the experimental treatment and more susceptible to its toxicities.)\n* Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then the patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.\n\nHematology\n\n* ANC \\> 1000\u002Fmm\\^3 without the support of filgrastim\n* WBC greater than or equal to 2500\u002Fmm\\^3\n* Platelet count greater than or equal to 80,000\u002Fmm\\^3\n* Hemoglobin \\> 8.0 g\u002FdL. Subjects may be transfused to reach this cut-off.\n\nChemistry\n\n* Serum ALT\u002FAST less than or equal to 5.0 x ULN\n* Serum creatinine less than or equal to 1.5 x ULN\n* Total bilirubin less than or equal to 2.0 mg\u002FdL, except in patients with Gilbert s Syndrome, who must have a total bilirubin \\\u003C 3.0 mg\u002FdL.\n* Patients must have completed any prior systemic therapy at the time of enrollment.\n\nNote: Patients may have undergone minor surgical procedures or limited field radiotherapy within the four weeks prior to enrollment, as long as related major organ toxicities have recovered to less than or equal to grade 1.\n\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n* Willing to sign a durable power of attorney.\n* Subjects must be co-enrolled on protocol 03-C-0277.\n\nEXCLUSION CRITERIA:\n\n* Participants who are pregnant or nursing because of the potentially dangerous effects of the treatment on the fetus or infant.\n* Concurrent systemic steroid therapy.\n* Active systemic infections requiring anti-infective treatment, coagulation disorders, or any other active or uncompensated major medical illnesses.\n* Advanced primary with impeding occlusion, perforation or bleeding, dependent on transfusion.\n* Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and AIDS).\n* History of major organ autoimmune disease.\n* Grade 3 or 4 major organ irAEs clinically attributed to anti-PD-1\u002FPD-L1 therapy.\n* Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immunecompetence may be less responsive to the experimental treatment and more susceptible to its toxicities.)\n* History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, or aldesleukin.\n* History of coronary revascularization or ischemic symptoms.\n* For select patients with a clinical history prompting cardiac evaluation: last known LVEF less than or equal to 45%.\n* Documented Child-Pugh score of B or C for hepatocellular carcinoma patients with known underlying liver dysfunction.\n* For select patients with a clinical history prompting pulmonary evaluation: known FEV1 less than or equal to 50%.\n* Patients who are receiving any other investigational agents.","72 Years",{"count":217,"type":21},332,[116],"Background:\n\nThe NCI Surgery Branch has developed an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment to over 200 patients with melanoma. Researchers want to know if TIL shrink s tumors in people with digestive tract, urothelial, breast, or ovarian\u002Fendometrial cancers. In this study, we are selecting a specific subset of white blood cells from the tumor that we think are the most effective in fighting tumors and will use only these cells in making the tumor fighting cells.\n\nObjective:\n\nThe purpose of this study is to see if these specifically selected tumor fighting cells can cause digestive tract, urothelial, breast, or ovarian\u002Fendometrial tumors to shrink and to see if this treatment is safe.\n\nEligibility:\n\n\\- Adults age 18-72 with upper or lower gastrointestinal, hepatobiliary, genitourinary, breast, ovarian\u002Fendometrial cancer, or glioblastoma refractory to standard chemotherapy.\n\nDesign:\n\nWork up stage: Patients will be seen as an outpatient at the NIH clinical Center and undergo a history and physical examination, scans, x-rays, lab tests, and other tests as needed.\n\nSurgery: If the patients meet all of the requirements for the study they will undergo surgery to remove a tumor that can be used to grow the TIL product.\n\nLeukapheresis: Patients may undergo leukapheresis to obtain additional white blood cells. (Leukapheresis is a common procedure, which removes only the white blood cells from the patient.)\n\nTreatment: Once their cells have grown, the patients will be admitted to the hospital for the conditioning chemotherapy, the TIL cells and aldesleukin. They will stay in the hospital for about 4 weeks for the treatment.\n\nFollow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking. Follow up visits will take up to 2 days.",[221,28,222,223,224],"Metastatic Colorectal Cancer","Metastatic Ovarian Cancer","Metastatic Breast Carcinoma","Metastatic Endocrine Tumors\u002F Neuroendocrine Tumors",[226,227,228,229,230],"Digestive Tract Cancers","Breast Cancer","Endocrine Tumors","Ovarian\u002FEndometrial Cancer","Genitourinary Cancer","2026-06-10",{"date":233,"type":43},"2026-06-11",{"date":235,"type":43},"2010-08-26",{"date":237,"type":21},"2029-12-27",{"name":49,"class":50},{"id":240,"slug":4,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":245,"targetDuration":4,"studyType":22,"phases":247,"briefSummary":248,"conditions":249,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":263},"100557070","NCT06533332","A Phase 1 Trial of ERX-315 in Participants With Advanced Solid Tumors","A First-in-Human, Phase 1 Safety, Tolerability, Pharmacokinetic, and Preliminary Efficacy Study of Escalating Doses of ERX-315 in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* Patients must be at least 18 years of age at the time of signing the informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n* Patients must have histologically or cytologically confirmed solid tumor, primarily including but not limited to breast, ovarian, pancreatic, endometrial and hepatocellular carcinoma, that is advanced unresectable and\u002For metastatic disease for whom standard therapies do not exist or are no longer effective\n* Patients must have measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n* Adequate baseline organ function and hematologic function\n* Life expectancy \\>3 months\n\nExclusion Criteria:\n\n* Systemic anti cancer therapy within 4 weeks of first dose of study drug\n* Major surgery (as defined by the Investigator) within 4 weeks of first dose of study drug.\n* Uncontrolled intercurrent illnesses\n* Known history of LIPA deficiency, such as Wolman disease or Cholesterol ester storage disease.",{"count":246,"type":21},36,[24],"This is a Phase 1 study to assess the safety of ERX-315 in patients with advanced solid tumors that have failed approved systemic therapies.",[250,251,222,252,253,28],"Advanced Solid Tumor","Metastatic Breast Cancer","Metastatic Endometrial Cancer","Metastatic Liver Cancer","2026-05-27",{"date":256,"type":43},"2026-05-29",{"date":258,"type":43},"2024-10-14",{"date":260,"type":21},"2027-06-30",{"name":262,"class":136},"EtiraRx Australia Pty Ltd",5,{"id":265,"slug":4,"hasResults":11,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":4,"eligibilityCriteria":269,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":270,"enrollmentInfo":271,"targetDuration":4,"studyType":22,"phases":273,"briefSummary":274,"conditions":275,"keywords":276,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":51},"100543900","NCT06361888","A Phase II\u002FIII Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer","A Multicenter, Randomized, Open-label, Active-controlled, Phase II\u002FIII Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine Versus Nab-paclitaxel Plus Gemcitabine as the First-line Treatment in Metastatic Pancreatic Cancer","Inclusion Criteria:\n\n1. Fully understand and voluntarily sign an informed consent form, willing and able to follow the study process;\n2. Age range is 18-75 years old (inclusive);\n3. Pancreatic cancer confirmed by histology or cytology;\n4. Stage IV metastasis Pancreatic cancer patients;\n5. Have not received previous systematic first line anti-tumor treatment in the stage of metastatic pancreatic cancer;\n6. According to RECIST 1.1, there is at least one measurable lesion;\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1;\n8. Expected survival time ≥ 12 weeks;\n\nExclusion Criteria:\n\n1. Use of systematic non-specific immunomodulatory therapy within 2weeks prior to the first dose；\n2. Presence of other malignancies in the past 5 years;\n3. Received major surgical surgery within 4 weeks before the first dose;\n4. Received palliative radiotherapy within 1 week before the first dose; received radical radiotherapy within 4 weeks before the first dose;\n5. Any known allergy to surufatinib or its components, camrelizumab, nab-paclitaxel, or gemcitabine;\n6. Received strong-inducers or strong-inhibitors of cytochrome P450 (CYP) 3A within 2 weeks or 5 half-lives (whichever is longer) before the first dose;\n7. Use of immunosuppressive drugs within 4 weeks before first dose;\n8. Known history of clinically significant liver disease, including active viral hepatitis infection or other active hepatitis or clinically significant moderate to severe cirrhosis;\n9. Patients who currently have hypertension that cannot be controlled by medication;","75 Years",{"count":272,"type":21},502,[116,62],"To evaluate the efficacy of surufatinib combined with camrelizumab, nab-paclitaxel, and gemcitabine versus nab-paclitaxel plus gemcitabine as the first-line treatment in metastatic pancreatic cancer",[28],[277],"First-line treatment in patients","2026-05-25",{"date":280,"type":43},"2026-05-28",{"date":282,"type":43},"2024-05-08",{"date":284,"type":21},"2028-05-31",{"name":286,"class":83},"Hutchmed",{"id":288,"slug":4,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":292,"eligibilityCriteria":293,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":22,"phases":296,"briefSummary":297,"conditions":298,"keywords":302,"overallStatus":307,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":51},"100638163","NCT07587827","Study Evaluating the Safety Feasibility and Efficacy of ODI-2001 Vaccine, a Personnalized Immunotherapy in Patients With Metastatic or Locally Advanced Colon Cancer or Pancreatic Cancer","A Phase 1, Open-label, Dose-escalation and Dose-expansion Study Evaluating the Safety Feasibility and Efficacy of ODI-2001 Vaccine, a Personnalized Immunotherapy in Patients With Metastatic or Locally Advanced Colon Cancer or Pancreatic Cancer","ODI-2001-01","Inclusion Criteria:\n\n* Patient capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n* Male or female of \\> 18 years of age\n* Histologically confirmed diagnosis of metastatic or locally advanced solid tumour: • Colorectal carcinoma with MicroSatellite Stable colorectal carcinoma (MSS) not eligible for surgery or other ablative therapies. • Pancreatic adenocarcinoma not eligible for surgery or other ablative therapies.\n* ECOG performance status 0 or 1\n* Baseline Tumoral evaluation (thoraco-abdomino-pelvic computed tomography) performed before the initiation of the standard first line-chemotherapy with at least one measurable lesion according to RECIST 1.1 criteria that can be accurately assessed at baseline and is suitable for repeated assessment.\n* Eligible to start a standard first line chemotherapy indicated in colorectal cancer (FOLFOX\u002FFOLFIRI\u002FFOLFIRINOX or FOLFOXIRI +\u002F- anti-VEGF\u002FEGF) pancreatic cancer (FOLFIRINOX\u002FNabPaclitaxel-Gemcitabine).\n* Adequate haematological, renal and hepatic laboratory requirements : • Haemoglobin \\> 9.0 g\u002FdL • White Blood Cells (WBC) \\> 2.5x109\u002FL including, absolute neutrophils count (ANC) \\> 1.5x109\u002FL, total lymphocytes count \\> 0.5x109\u002FL • Platelet's count \\> 100x109\u002FL• Serum alkaline phosphatase (PAL) ≤ 3 x ULN in the absence of liver or bone metastases and ≤ 5 x ULN in patients with documented bone or liver metastases• Serum transaminases (alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN in the absence of liver metastases and ≤ 5 x ULN in case of liver metastases\n\n  • Total bilirubin ≤ 1.5 x ULN• Albumin ≥ 30 g\u002FL • Glomerular Filtration Rate ≥ 50 mL\u002Fmin (according to Modification of the Diet in Renal Disease \\[MDRD\\] formula or Cockroft \\& Gault formula)\n* Adequate cardiac function with QTc \\\u003C 450 msec on baseline ECG, using the Fridericia correction cQTcF formula\n* Life expectancy of at least 6 months\n* Patient willing and able to comply with scheduled visits and exams during the follow-up and treatment compliance of the protocol, for the duration of the study including : • mandatory blood sampling (3 blood sampling) • mandatory biopsy of the tumor following enrolment in STEP 1 if no archived material dated less than 2 years is available in sufficient quality or quantity and a mandatory biopsy at 2 months after the initiation of ODI-2001 vaccine administration.\n* Men who are sexually active with women of childbearing potential must agree to use contraceptive method during the ODI-2001 treatment period and for at least 4 months after the last ODI-2001 administration. The individual methods of contraception may be determined in consultation with the investigator and it must have a failure rate of less than 1% per year.\n* A female participant is eligible to participate if she is not pregnant (negative urinary or serum pregnancy test), not breastfeeding, and at least one of the following conditions applies: • Not a woman of childbearing potential OR • Women of childbearing potential who agrees to apply effective contraception method during the treatment period and for at least 4 months after the last dose of study treatment. Effective contraception methods include a combination of any of the following (unless method is abstinence or sterilization, in which only one method is required): - Use of oral, injected, or implanted hormonal methods of contraception, or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C 1%). In case of use of oral contraception, women should have been stable on the same pill for a minimum of 6 months before taking study treatment. - Placement of an intrauterine device or intrauterine system. - Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fvaginal suppository. - Total abstinence - Female sterilization at least eight weeks before taking study treatment. - Male sterilization (at least six months prior to screening)\n* Patient must be affiliated to a social health insurance regimen\n\nInclusion criteria for ENROLMENT STEP 1 :\n\nFirst tumoral evaluation shows disease response with the following definition:\n\n* Colorectal carcinoma: A decrease of at least 30% or more in the sum of the diameters of target lesions compared to the initial sum of diameters (Baseline assessment) = at least partial response definition according to RECIST 1.1 definition.\n* Pancreatic carcinoma: A decrease of at least 20% or more in the sum of the diameters of target lesions compared to the initial sum of diameters (Baseline assessment) = adaptative RECIST 1.1 definition.\n\n  * Availability of tumoral material in sufficient quality and quantity in FFPE to performed dB209 manufacturing (5-10 slides according to tissue surface area) + tumoral microenvironment assessment (10 slides). In case of lack of tumoral material to performed the mandatory 2 analysis, a new biopsy should be organized.\n\nInclusion criteria for ENROLMENT STEP 2\n\n* Second tumoral evaluation shows disease response with the following definition:\n\n  * Colorectal carcinoma: A decrease of at least 30% or more in the sum of the diameters of target lesions compared to the initial sum of diameters (Baseline assessment) = at least partial response definition according to RECIST 1.1 definition.\n  * Pancreatic carcinoma: A decrease of at least 20% or more in the sum of the diameters of target lesions compared to the initial sum of diameters (Baseline assessment) = adaptative RECIST 1.1 definition.\n* Patient eligible for a 6-week chemotherapy break, with the start of maintenance treatment beginning in week 7.\n\nExclusion Criteria:\n\n* Patients with \\>10% hepatic involvement as per investigator\n* Exposure to any investigational agent within 30 days of enrolment.\n* Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study\n* History of any second malignancy within 2 years with the exception of malignancies with a negligible risk of metastasis or death (e.g. adequately treated carcinoma-in situ of the breast or the cervix, melanoma-in-situ, prostate cancer with Gleason grade ≤6 and prostate specific antigen within normal range).\n* Known or suspected history of immunosuppression (severe auto-immune or immunodeficiency disease) including history of invasive opportunistic infections (e.g tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystis, aspergillosis) despite infection resolution. Presence or suspicion of active bacterial, fungal or viral infections, or uncontrolled fever\n* Patients with major surgery within 4 weeks from enrolment\n* Previous vaccination (either therapeutic and\u002For prophylactic) against cancer\n* Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, ototoxicity, vitiligo, and the laboratory values defined in the inclusion criteria.\n* Patients under chronic treatment with systemic corticoids or other immunosuppressive drugs (e.g., cyclosporine) unless used at dose levels that are not immunosuppressive (e.g. Prednisone at 10 mg\u002Fday or less or as inhaled steroid at doses used for the treatment of asthma) up to 14 days before pre-enrolment.\n* Is receiving growth factors including, but not limited to, granulocyte colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), erythropoietin, etc. within 4 weeks from enrolment\n* Known history of Positive serology for Human Immunodeficiency Virus (HIV) or Hepatitis C Virus (HCV); presence of HBs antigen in the serum\n* History of severe auto-immune or immunodeficiency disease\n* Known allergy to any of the components of ODI-2001 (e.g. egg or gentamycin)\n* Known allergy, or history of serious adverse reaction to vaccines such as anaphylaxis, hives, or respiratory difficulty\n* Planned to receive yellow fever or other live (attenuated) vaccines during the course of the study\n* Recent or active clinically significant infection requiring therapy at the time of first dose\n* Any persistent or unresolved drug-related toxicity following previous treatment\n* Myocardial infarction or stroke within previous 6 months, unstable angina, serious uncontrolled cardiac arrhythmia, history of myocarditis, or congestive heart failure\n* Known symptomatic malignant brain lesion\n* Patients with any serious uncontrolled disease or psychiatric condition that, in the opinion of the Investigator, might interfere with the patient's participation in the trial or interfere with the interpretation of trial results",{"count":295,"type":21},77,[24],"This is a phase 1, open-label, multicentric study evaluating the safety, feasibility and efficacy of ODI-2001, a personnalized therapeutic cancer vaccine composed of DNA neoantigen vaccine, Modified Vaccinia virus Ankara (MVA) viral adjuvant and anti-CTLA4 (ipilimumab), in patients with metastatic or locally advanced colorectal or pancreatic cancer. The study includes a dose-escalation phase to determine the maximum tolerated dose (MTD) followed by an expansion phase to evaluate efficacy in terms of progression-free survival",[299,300,28,301],"Metastatic Colorectal Cancer (CRC)","Locally Advanced Colorectal Cancer","Locally Advanced Pancreatic Cancer",[303,304,305,306],"vaccine","pancreas","colorectal","phase 1","NOT_YET_RECRUITING","2026-05-11",{"date":310,"type":43},"2026-05-14",{"date":312,"type":21},"2026-11-01",{"date":314,"type":21},"2031-05-01",{"name":316,"class":136},"Centre Georges Francois Leclerc",{"id":318,"slug":4,"hasResults":11,"nctId":319,"briefTitle":320,"officialTitle":320,"acronym":4,"eligibilityCriteria":321,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":322,"targetDuration":4,"studyType":22,"phases":324,"briefSummary":326,"conditions":327,"keywords":329,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":340,"locationsCount":104},"100413619","NCT04665947","First-in-human Study of the Theranostic Pair [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G in Pancreatic Cancer","Inclusion Criteria:\n\n\\[68Ga\\]Ga DOTA-5G PET\u002FCT Inclusion Criteria:\n\n1. Ability to understand and willingness to sign a written informed consent document.\n2. Age 18 or more years\n3. Confirmed presence of locally advanced, unresectable or metastatic pancreatic adenocarcinoma (other pancreatic malignant histologies are excluded) with measurable disease per RECIST (version 1.1) (i.e. at least 1 lesion \\> 1 cm or lymph node \\> 1.5 cm in short axis)\n4. Participant must have documented tumor progression during or following at least one prior systemic regimen as established by CT or MRI scan within 28 days of enrollment\n5. Eastern Cooperative Oncology Group Performance Status ≤ 2\n6. Participant must have completed prior chemotherapy at least 2 weeks (washout period) prior to \\[68Ga\\]Ga DOTA-5G PET scan. Any clinically significant toxicity (with the exceptions of hair loss and sensory neuropathy) related to prior therapy resolved to Grade 1 or baseline.\n7. Hematologic parameters defined as:\n\n   1. Absolute neutrophil count (ANC) ≥ 1000 cells\u002Fmm3\n   2. Platelet count ≥ 100,000\u002Fmm3\n   3. Hemoglobin ≥ 8 g\u002FdL\n8. Blood chemistry levels defined as:\n\n   1. AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN)\n   2. Total bilirubin ≤ 2 times ULN\n   3. Creatinine ≤ 2 times ULN\n9. Anticipated life expectancy ≥ 3 months\n10. Able to remain motionless for up to 30-60 minutes per scan\n\n\\[177Lu\\]Lu DOTA-ABM-5G therapy Inclusion Criteria:\n\n1. Completion of entry into \\[68Ga\\]Ga DOTA-5G PET study and completion of scan\n2. The presence of at least one measurable disease by \\[68Ga\\]Ga DOTA-5G PET\u002FCT (SUVmax\\>2-fold above normal lung or liver)\n\nExclusion Criteria:\n\n* \\[68Ga\\]Ga DOTA-5G and \\[177Lu\\]Lu DOTA-ABM-5G therapy Exclusion Criteria:\n\n  1. Participant on any chemical anticoagulant including antiplatelet agents (excluding ASA)\n  2. Participants with Class 3 or 4 NYHA Congestive Heart Failure\n  3. Clinically significant bleeding within two weeks prior to trial entry (e.g. gastrointestinal bleeding, intracranial bleeding)\n  4. Pregnant or lactating women\n  5. Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e. larger than what is required for placement of a central venous access, percutaneous feeding tube, or biopsy) within 28 days prior to study day 1 or anticipated surgery within the subsequent 6 weeks\n  6. Has an additional active malignancy requiring therapy within the past 2 years\n  7. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy\n  8. Psychiatric illness\u002Fsocial situations that would interfere with compliance with study requirements\n  9. Previous radiation therapy for the treatment of advanced or metastatic disease\n  10. Cannot undergo PET\u002FCT scanning because of weight limits (350 lbs)\n  11. INR\\>1.2; PTT\\>5 seconds above UNL",{"count":323,"type":21},30,[325],"EARLY_PHASE1","This is a Phase I, first-in-human study to evaluate the safety and efficacy of the \\[68Ga\\]Ga DOTA-5G and \\[177Lu\\]Lu DOTA-ABM-5G theranostic pair in patients with locally advanced or metastatic pancreatic adenocarcinoma (PDAC).",[28,328],"Locally Advanced Pancreatic Adenocarcinoma",[330,331,332,333],"integrin","metastatic pancreatic cancer","PET","theranostic","2026-04-23",{"date":336,"type":43},"2026-04-29",{"date":338,"type":43},"2020-12-18",{"date":161,"type":21},{"name":341,"class":136},"University of California, Davis",{"id":343,"slug":4,"hasResults":11,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":347,"eligibilityCriteria":348,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":349,"targetDuration":4,"studyType":22,"phases":351,"briefSummary":352,"conditions":353,"keywords":355,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":363,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":104},"100553243","NCT06483555","Basal-like PDAC Treated With Gemcitabine, Erlotinib, and Nab-paclitaxel","Subjects With Advanced Basal-like Pancreatic Adenocarcinoma Treated With Gemcitabine, Erlotinib and Nab-paclitaxel (PANGEA) Versus Subjects With Classical Pancreatic Adenocarcinoma Treated With Triplet Standard of Care Therapy.","PANGEA","Inclusion Criteria:\n\n* Written informed consent was obtained to participate in the study and HIPAA authorization for release of personal health information. Subjects is willing and able to comply with study procedures based on the judgment of the investigator.\n* Age ≥ 18 years at the time of consent.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 Histological or cytological evidence\u002Fconfirmation of unresectable, borderline resectable, or metastatic (basal-like and classical) pancreatic adenocarcinoma.\n* The subject must consent to a mandatory pre-study biopsy if archival tissue is not available or sufficient.\n* Subjects may have received prior standard-of-care (SOC) neoadjuvant therapy and may have received up to two cycles of first-line FOLFIRINOX or NALIRIFOX.\n* A subject with prior brain metastasis may be considered if they have completed their treatment for brain metastasis at least 4 weeks prior to study treatment have been off of corticosteroids for ≥ 2 weeks and are asymptomatic.\n\nExclusion Criteria:\n\n* Disease is not measurable according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1\n* Not having histological or cytological evidence\u002Fconfirmation of metastatic pancreatic adenocarcinoma.\n* Treatment with any investigational drug or prior cancer treatment within 28 days prior to study treatment",{"count":350,"type":21},104,[24,116],"This Phase I\u002FII clinical trial is being conducted at multiple centers to find out whether adding a low dose of EGFR blocking drugs to the standard chemotherapy combination of gemcitabine and nab paclitaxel (GnP) is safe, tolerable, and helpful for people with advanced pancreatic cancer. All participants are first tested with a tool called PurIST, which classifies tumors as either \"basal-like\" or \"classical.\" People with basal-like tumors will receive GnP plus erlotinib during Phase I so researchers can determine the safest and most effective dose. Once that dose is identified, the study moves to Phase II, where people with basal-like tumors will be randomly assigned to receive either GnP alone or GnP with erlotinib. Phase II may also test new drug combinations if new treatments become approved during the study period. Overall, the trial plans to include up to about 52 basal-like patients in Phase I, roughly 82 basal-like patients in Phase II, and at least 52 classical patients, with the possibility of enrolling more if needed. People whose tumors are classified as classical will continue with standard treatments recommended by their doctors or other clinical trials. Across the entire study, researchers will carefully track long-term outcomes such as overall survival, how long patients live before the cancer progresses, and how well their tumors respond to treatment.",[175,28,354],"Basal Cell Neoplasm",[356,357,358,359,360,361],"safety","tolerability","efficacy","EGFR inhibitors","gemcitabine","nab-paclitaxel","2026-04-22",{"date":334,"type":43},{"date":365,"type":43},"2025-02-06",{"date":367,"type":21},"2027-08",{"name":369,"class":136},"UNC Lineberger Comprehensive Cancer Center",{"id":371,"slug":4,"hasResults":11,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":375,"eligibilityCriteria":376,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":270,"enrollmentInfo":377,"targetDuration":4,"studyType":22,"phases":379,"briefSummary":380,"conditions":381,"keywords":382,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":386,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":394},"100444313","NCT05065801","Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients","Randomized Phase II Trial Evaluating the Efficacy of a Sequential Treatment Gemcitabine Plus Nab-paclitaxel (Gembrax) Followed by Folfirinox Versus Folfirinox Alone in Patients Treated in First Metastatic Line Pancreatic Cancer","GABRINOX2","Inclusion Criteria:\n\n1. Male or female aged 18 to 75 on the date the consent is signed.\n2. Histologically or cytologically proven metastatic pancreatic adenocarcinoma. The definitive diagnosis of pancreatic adenocarcinoma metastases will be made by integrating the histopathological data in the context of the radiological data.\n3. One or more metastatic lesion (s) measurable (Recist 1.1) by Thoraco-Abdomino-Pelvic scanner (or hepatic MRI and Thoraco-Abdomino-Pelvic scanner not injected, if the patient is allergic to the product of contrast).\n4. Previous treatment (including radiochemotherapy) for the non-metastatic disease authorized if a delay ≥ 6 months between the last treatment and the recurrence is respected.\n5. WHO performance status ≤ 1\n6. Uracilemia \\\u003C16 ng \u002F ml\n7. Acceptable hematological assessment at inclusion (obtained within 14 days before the start of treatment) defined by: • Neutrophils ≥ 2 × 109 \u002F L; • Platelets ≥ 100,000 \u002F mm3 (100 × 109 \u002F L); • Hemoglobin ≥ 9 g \u002F dl.\n8. Acceptable renal and hepatic function at inclusion (obtained within 14 days before the start of treatment) defined by: • AST and ALT ≤ 2.5 x upper limit of the norm (ULN), unless liver metastases are present in this case AST and ALT ≤ 5 × ULN is allowed; • Total bilirubin ≤ 1.5 x ULN; • Serum creatinine within the norm limits or calculated clearance ≥ 50ml \u002F min for patients with a serum creatinine value above or below the norm values (clearance calculated by the CKD-EPI formula).\n9. Calcemia AND magnesemia AND kalaemia ≥ LLN and ≤ 1.2 x ULN\n10. If the patient is sexually active, he must agree to use contraception deemed adequate and appropriate by the investigator throughout the period of administration of the study drug and up to 6 months after discontinuation of treatment for women and for men.\n11. Signature of consent before any procedure specific to the study.\n12. Affiliated with the French national social security.\n\nExclusion Criteria:\n\n1. Known brain metastasis.\n2. Previous treatment with radiotherapy, surgery, chemotherapy or experimental therapy for the treatment of metastatic disease.\n3. Major surgery, other than diagnostic surgery (that is, surgery done to obtain a diagnostic biopsy without organ harvesting), within 4 weeks of day 1 of study treatment.\n4. Known Gilbert's syndrome or homozygous for know UGT1A1 \\* 28\n5. Other concomitant cancer or history of cancer, except cervical cancer in situ treated, skin basal or squamous cell carcinoma, superficial bladder tumor (Ta, Tis, and T1) or a tumor with a good prognosis treated curatively without chemotherapy and without any sign of disease in the 3 years preceding inclusion.\n6. Patients with high cardiovascular risk, including, but not limited to, coronary stent or myocardial infarction within the past 6 months.\n7. Peripheral sensory neuropathy ≥ grade 2 at the time of inclusion.\n8. ECG with a QTc interval greater than 450 ms for men and greater than 470 ms for women\n9. Any other concomitant and unbalanced disease or serious disturbance that may interfere with the patient's participation in the study and his safety during the study (eg severe hepatic, renal, pulmonary, metabolic, or psychiatric disorders)\n10. Allergy or intolerance to any study drug (gemcitabine, nab-paclitaxel, oxaliplatin, irinotecan, 5-FU) or any excipient (e.g., fructose) as described in the sections \" contraindication or special warnings and precautions\" or \"prescribing information\" of the summary of product characteristics indications.\n11. Pregnant or breastfeeding women. Women of childbearing potential must have a negative pregnancy test (serum β-hCG) within 72 hours prior to inclusion.\n12. Patients on vitamin K antagonists (e.g., Coumadin) (modifications to treatment may be required prior to inclusion).\n13. Treatment with brivudine within 4 weeks before or after treatment with 5-fluorouracil (due to a potentially fatal interaction).\n14. Active and uncontrolled bacterial, viral, or fungal infections requiring systemic treatment.\n15. Active HIV infection, known hepatitis B or C infection.\n16. History of peripheral arterial disease (e.g., claudication, Buerger's disease), chronic inflammatory bowel disease or rectal disease, pulmonary fibrosis or interstitial pneumonia.\n17. Administration of a live attenuated vaccine within 10 days before inclusion and up to 6 months post-treatment.\n18. Patient refusal or inability to comply with study procedures.\n19. Inability to undergo follow-up for geographical, social, or psychological reasons.\n20. Participation in another clinical trial involving an investigational product within the 30 days prior to inclusion.\n21. Legal incapacity (patient under guardianship or guardianship).",{"count":378,"type":21},162,[116],"The aim of this study is to evaluate the efficacy of sequential treatment (Gabrinox) comprising Gembrax regimen (Gemcitabine -Abraxane) followed by the Folfirinox regimen (5FU, Oxaliplatin and Irinotecan) compared to folfirinox alone in patients treated in first metastatic line pancreatic cancer",[28],[383,384],"pancreatic","cancer","2026-04-10",{"date":387,"type":43},"2026-04-15",{"date":389,"type":43},"2022-01-11",{"date":391,"type":21},"2028-06-30",{"name":393,"class":136},"Institut du Cancer de Montpellier - Val d'Aurelle",8,{"id":396,"slug":4,"hasResults":11,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":4,"eligibilityCriteria":400,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":401,"targetDuration":4,"studyType":22,"phases":403,"briefSummary":404,"conditions":405,"keywords":407,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":412,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":418,"locationsCount":104},"100468487","NCT05380414","Profiling Program of Advanced\u002FMetastatic Pancreatic Cancer Patients","A Single-center, Prospective Profiling Program of Advanced\u002FMetastatic Pancreatic Cancer Patients","Inclusion Criteria:\n\n* Male or female patient \\> 18 years\n* metastatic or advanced PDAC\n* Patient pretreated with no more than one prior systemic chemotherapy for metastatic\u002Fadvanced disease (radiotherapy is not counted as a line of therapy).\n* Availability of an archival representative FFPE tumor sample from primary tumor (surgery or diagnostic biopsy) and\u002For from metastatic lesion if metastatic disease at initial diagnosis with associated pathology report from an archival tumor block.\n* Life expectancy \\> 3 months\n* PS score 0 or 1.\n\nExclusion Criteria:\n\n* Curative therapy available\n* Any condition contraindicated with blood sampling procedures required by the protocol.\n* Known additional malignancy that is progressing or requires active treatment. Exceptions include adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer.\n* Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.",{"count":402,"type":21},750,[147],"The proposal is to implement a molecular screening program for advanced\u002Fmetastatic pancreatic cancer patients before the initiation of 1st line treatment in order to allow a better selection of patients for rationale personalized medicine with targeted agents and\u002For combination involving a chemotherapy backbone.",[28,406],"Advanced Pancreatic Cancer",[408,409,410],"Molecular screening","Genomic profiles","Transcriptomic profiles","2026-03-26",{"date":413,"type":43},"2026-03-31",{"date":415,"type":43},"2022-07-01",{"date":417,"type":21},"2027-09-01",{"name":419,"class":136},"Centre Leon Berard",{"id":421,"slug":4,"hasResults":11,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":4,"eligibilityCriteria":425,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":426,"targetDuration":4,"studyType":22,"phases":427,"briefSummary":428,"conditions":429,"keywords":432,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":104},"100409010","NCT04605913","Nab-Paclitaxel + Cisplatin + Gemcitabine + TTF in pt. w\u002F Metastatic PAC","A Phase I\u002FIb Pilot Trial, Single Arm, Open Label, of Protein-Bound Paclitaxel, Cisplatin, and Gemcitabine (GCN) Combined With Tumor Treatment Fields (TTF) in Patient With Metastatic Pancreatic Adenocarcinoma","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed pancreatic adenocarcinoma or adeno-squamous carcinoma with liver metastasis.\n\n   1. Subjects with additional sites of metastasis, except known brain metastasis, are eligible.\n   2. Histologies excluded include squamous, small cell carcinoma, and acinar cell carcinoma. However, adeno-squamous histology can be enrolled.\n   3. Patients who have recurrence or metastasis after surgery and adjuvant therapy do not need repeat biopsy for confirmation of recurrence if clinical suspicion is high per scans (MRI\u002FCT scan), with and without CA 19-9 elevation, specifically if biopsy is unsafe or technically difficult.\n2. Patients with no prior lines of therapy for the treatment of stage IV metastatic disease.\n\n   1. Patients could have had prior neoadjuvant or adjuvant chemotherapy or chemo-radiotherapy.\n\n   i. Patients who received gemcitabine-based adjuvant chemotherapy can enroll if they progress greater than 6 months after completion of the therapy; ii. Patients who progress while on adjuvant FOLFIRINOX can enroll immediately.\n3. Male and female patients at least 18 years of age\n4. Laboratory data as specified below:\n\n   Hematology:\n\n   \\- ANC greater than 1500 cells\u002Fmm3,\n\n   \\- platelet count greater than 100,000 cells\u002Fmm3, and\n\n   \\- Hemoglobin greater than 8 g\u002FdL.\n   * Hepatic\n\n     * Total bilirubin less than 1.5 X ULN;\n     * alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than 3 X ULN.\n\n   For patients with known liver metastases or liver neoplasms: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than 6.0 X ULN and total bilirubin less than 3 x ULN.\n   * Renal:\n\n     * serum creatinine WNL or creatinine clearance greater than 50 mL\u002Fmin.\n5. QT intervals: QTc less than or equal to 470 msec for men and less than or equal to 490 msec for women. (As measured by Hodges' Equation: QTc = QT + 1.75(rate-60) where QTc = corrected QT interval and rate = ventricular rate\u002Fmin).\n6. Estimated life expectancy of at least 3 months\n7. ECOG Performance Status 0-1.\n8. Ability to operate the Novo TTF-100L (P) system.\n9. Patients must have measurable disease on scans per RECIST 1.1.\n10. Negative serum pregnancy test within 14 days prior to the first dose of study therapy for women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally post-menopausal for at least 24 consecutive months (i.e., who has had menses any time in the preceding 24 consecutive months). Sexually active WCBP and male subjects must agree to use adequate methods to avoid pregnancy (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study and for 28 days after the completion of study treatment.\n\nExclusion Criteria:\n\n1\\. Previous front-line therapy for metastatic disease.\n\n1. Patients with known brain metastasis.\n2. Cardiac conduction abnormalities such as 2nd and 3rd heart-block requiring a pacemaker.\n3. Patient with cardiac or abdominal pacemakers or stimulators.\n4. Significant risk of cardiac drug toxicity due to congestive heart failure or history of myocardial infarction.\n5. Any other condition including but not limited to major co-morbidities, which in the opinion of the investigator would render the patient ineligible.\n6. Concomitant use of drugs that have black box warning of Torsades de Pointes will also be prohibited if cannot be replaced by another drug.\n7. Known sensitivity to conductive hydrogels.\n\n10\\. Patients who are pregnant or breastfeeding.",{"count":171,"type":21},[24,116],"This is a Phase I\u002FIb trial, single-center, non-randomized, open-label study of Protein-bound Paclitaxel, Cisplatin, And Gemcitabine (GCN) Combined with Tumor Treatment Fields (TTF) and G+TTF maintenance therapy in patients with metastatic pancreatic cancer.",[430,28,175,431],"Pancreas Cancer","Metastatic Adenocarcinoma",[433,434,435,436,437,438],"GCN","TTF","Paclitaxel","Cisplatin","Gemcitabine","Tumor Treatment Fields","2026-02-23",{"date":441,"type":43},"2026-02-25",{"date":443,"type":43},"2022-04-01",{"date":445,"type":21},"2028-10-01",{"name":447,"class":136},"Mayo Clinic",{"id":449,"slug":4,"hasResults":11,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":453,"eligibilityCriteria":454,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":455,"targetDuration":4,"studyType":22,"phases":457,"briefSummary":458,"conditions":459,"keywords":461,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":468,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":474,"locationsCount":476},"100582267","NCT06861088","The Effect of Kinisoquin™ on Thromboembolic Events in Patients With Metastatic or Locally Advanced Pancreatic Cancer","A Randomized, Placebo-Controlled, Double-Blind Phase 3 Trial Comparing, Relative to Placebo, the Effect of Kinisoquin™ on Thromboembolic Events in Patients With Metastatic or Locally Advanced Pancreatic Cancer (CATIQ P3)","CATIQ P3","Inclusion Criteria:\n\n1. Participants must have histological or cytological confirmed pancreatic adenocarcinoma malignancy that is metastatic (including recurrent with distant metastases) or locally advanced.\n2. Receiving first line chemotherapy (within 45 days of first dose of study drug) Note: subjects must be either initiating first systemic cancer therapy regimen following initial diagnosis or initiating first cycle of chemotherapy for disease recurrence.\n3. Minimum age 18 years.\n4. Life expectancy of greater than 4 months.\n5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n6. Participants must have preserved organ and marrow function as defined by:\n\n   * Platelet count ≥ 100,000\u002FmcL.\n   * Prothrombin time (PT) and partial thromboplastin time (PTT) ≤ 1.5x institutional upper limit of normal (ULN).\n   * Total bilirubin ≤ 3x ULN without liver metastases and \\\u003C 5x ULN in presence of liver metastases.\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3x ULN without liver metastases and \\\u003C 5x ULN in the presence of liver metastases\n   * Estimated creatinine clearance (CrCl \\> 30 mL\u002Fmin).\n7. Willingness of women of child-bearing potential and men to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation until at least 4 weeks after study completion.\n8. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Participants with known brain metastases\n2. Prior history of documented thromboembolic event within the last 12 months (excluding central line associated events whereby patients completed anticoagulation)\n3. Active bleeding or high risk for bleeding (e.g. known acute gastrointestinal ulcer)\n4. History of significant hemorrhage (requiring hospitalization or transfusion) outside of a surgical setting within the last 24 months\n5. Familial bleeding diathesis\n6. Known diagnosis of disseminated intravascular coagulation (DIC)\n7. Currently receiving anticoagulant therapy\n8. Current daily use of aspirin (\\> 100mg daily), Clopidogrel (Plavix), cilostazol (Pletal), aspirin-dipyridamole (Aggrenox) (within 10 days) or considered to use regular use of higher doses of non-steroidal anti-inflammatory agents as determined by the treating physician (e.g. ibuprofen \\> 800mg daily or equivalent)\n9. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n10. Known intolerance to the active ingredient of Kinisoquin™, isoquercetin, nicotinic acid, or ascorbic acid (including known G6PD deficiency)\n11. Females of child-bearing potential who are lactating, have a positive pregnancy test at Screening, or are unwilling to use acceptable contraception prior to study entry and for the duration of study participation until at least 4 weeks after study completion.\n12. Participation in other clinical trials The study is open to any individual who has a metastatic or locally advanced pancreatic adenocarcinoma malignancy without discrimination based on race, religion, political affiliation, or other criteria.",{"count":456,"type":21},480,[62],"The aim of this Phase 3 study is to evaluate the efficacy of Kinisoquin™ as compared to the placebo in prevention of thromboembolic events in patients with metastatic or locally advanced pancreatic cancer.",[460,28,328],"Venous Thromboembolism",[28,175,462,463,464,465,466,301],"Thromboembolism","Cancer-associated Thrombosis","Deep Vein Thrombosis","Pulmonary Embolism","Chemotherapy-associated VTE","2026-01-29",{"date":469,"type":43},"2026-02-02",{"date":471,"type":43},"2025-12-19",{"date":473,"type":21},"2029-10-31",{"name":475,"class":83},"Quercis Pharma AG",3,{"id":478,"slug":4,"hasResults":11,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":482,"eligibilityCriteria":483,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":484,"targetDuration":4,"studyType":22,"phases":486,"briefSummary":487,"conditions":488,"keywords":505,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":530,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":51},"100374021","NCT04150042","SHARON: A Clinical Trial for Metastatic Cancer Using Chemotherapy and Patients' Own Stem Cells","SHARON: Study of Metastatic Cancers in Patients Using Autologous Stems Cells and Potentiated Redox Cycling to Overcome Drug Resistance to Nitrogen Mustard Derivatives","SHARON","Inclusion Criteria\n\n* Age ≥ 18 years.\n* Pancreatic or breast cancer, as described below.\n* Stage IV (based on AJCC staging guidelines) at the time of enrollment.\n\n  a. Note that potential subjects with stage IV cancer that have had a complete response from prior chemotherapy are still potentially eligible.\n* Expected survival time ≥ 6 months, as determined by the investigator.\n* Life expectancy not severely limited by diseases other than malignancy, as determined by the investigator.\n* Karnofsky score ≥ 60%.\n* No chemotherapy within 2 weeks of enrollment.\n* Prior surgical resection or ablation of the primary tumor is allowed but not required.\n* If post-surgical, the subject must be at least 28 days post-op with the surgical wounds healed and significant complications resolved.\n* Potential subjects who have received previous chemotherapy and\u002For PARP inhibitors may be enrolled.\n* Measurable or non-measurable disease by the revised response evaluation criteria in solid tumors (RECIST) v.1.1.\n* For potential subjects with a germline BRCA1, BRCA2, or PALB2 mutation:\n\n  a. The mutation must be known to be deleterious or suspected to cause functional impairment as assessed by a CLIA-certified laboratory according to the variant classification criteria described in the study protocol.\n* For potential subjects with somatic BRCA1, BRCA2, or PALB2 mutations:\n\n  1. The mutation must be a known or suspected deleterious mutation as assessed by a CLIA-certified laboratory according to the variant classification criteria described in the study protocol.\n  2. There must be biallelic loss or inactivation of the mutated BRCA1, BRCA2, or PALB2 gene as assessed by a CLIA-certified laboratory.\n  3. The Genetics Review Committee for this trial, which is comprised of a core group of investigators and whose actions are performed in accordance with the committee's charter, must agree that the biallelic mutations are deleterious or suspected deleterious.\n* For subjects without a BRCA1, BRCA2, or PALB2 mutation\n\n  1. Subject must have received at least 16 weeks of first-line (platinum-based\\*) chemotherapy with no evidence of treatment failure, where treatment failure is defined as growing tumors, new lesions, or a steadily rising tumor marker during or within eight weeks of completion of the first line therapy.\n  2. \\* Subjects can also have been treated with FOLFIRINOX but switched to FOLFIRI due to oxaliplatin side effects.\n* For potential subjects with pancreatic cancer:\n\n  1. Pancreatic ductal adenocarcinoma or pancreatic acinar cell carcinoma.\n  2. If the potential subject has had surgical resection of the primary tumor, then there must be no evidence of disease progression between the time of surgical resection of the primary tumor and screening for enrollment if the patient is seeking enrollment in the immediate post-surgery period.\n* For potential subjects with breast cancer:\n\n  1. Adenocarcinoma of the breast.\n  2. HER2-negative cancer as per American Society of Clinical Oncology\u002FCollege of American Pathologists human epidermal growth factor receptor 2 (HER2) testing in breast cancer guidelines.\n  3. Male or female sex.\n* Histological or cytological confirmation of the primary cancer diagnosis is required.\n* Metastatic disease must be histologically or cytologically confirmed unless in the clinical judgment of the investigator a biopsy is not needed for diagnostic purposes.\n* Female participants of childbearing potential must agree to do one of the following from the time of signing of the informed consent through 6 months after the last dose of melphalan:\n\n  1. Simultaneously practice two effective barrier methods of contraception. Oral and injectable contraceptives are not allowed. Barrier methods of birth control (e.g., diaphragm and spermicide, or condom and spermicide) are required.\n  2. Practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods, and withdrawal) are not acceptable methods of contraception.\n* Male participants:\n\n  1. Unless the male is in a monogamous relationship with a female that does not have child-bearing potential, male subjects (even if surgically sterilized) must agree to do one of the following from the time of signing of the informed consent through 6 months after the last dose of melphalan:\n\n     1. Practice effective barrier contraception, plus a second method of effective contraception.\n     2. Practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods, and withdrawal) are not acceptable methods of contraception.\n\nExclusion Criteria\n\n* Rapid disease progression or clinical features concerning for onset of rapid symptomatic deterioration, as determined by the investigator.\n* Biliary tract obstruction.\n* Current cholangitis. A biliary stent in situ does not otherwise exclude protocol participation.\n* A history of only one episode of cholangitis and fewer than 30 days have passed since discontinuation of antibiotic treatment.\n* A history of multiple episodes of cholangitis and after discussion between the site study team and sponsor medical monitor and careful evaluation for suitability the patient is deemed to be unsuitable for the trial due to risk of recurring cholangitis.\n* Portal hypertension.\n* Sinistral portal hypertension.\n* Obliteration or significant obstruction of the major veins or arteries (e.g., portal vein, superior mesenteric artery, superior mesenteric vein).\n* Clinically significant malignant ascites or malignant pleural effusion, as determined by the investigator.\n* Metastatic lesion to the heart or eye.\n* Chemotherapy for an indication other than treatment of the current cancer within the past 1 year with a more than 30% risk of recurrence as determined by the investigator.\n* Known or suspected metastatic involvement of the central nervous system.\n* Left ventricular ejection fraction less than 45% by Multigated Acquisition Scan or echocardiogram (or significantly below the lower limit of normal for the specific test).\n* Clinically significant structural heart disease or vascular disease.\n* Myocardial infarction within 6 months prior to enrollment; New York Heart Association (NYHA) Class III or IV heart failure; angina; uncontrolled ventricular arrhythmias; or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.\n* Clinically significant prolongation of QTc (Bazett formula) on EKG, defined as \\> 0.45 s in males and \\> 0.47 s in females.\n* Severe hypertension, which is defined as the presence of any of the following:\n\n  1. History of hypertensive crisis, hypertensive emergency, or malignant hypertension within the last year.\n  2. Sustained or persistent systolic BP \\> 165 mm Hg or diastolic \\> 110 mm Hg.\n* Other clinically significant cardiovascular disease.\n* NOTE:\n\n  1. A past history of severe hypertension that is well-controlled with therapy or that was addressed by removal of the cause (e.g., removal of a medicine that caused the severe hypertension) is not an exclusion criterion.\n  2. The presence of a pacemaker is not a contraindication and is not considered an exclusion criterion\n* History or evidence of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis).\n* If a smoker, refusal to stop smoking for the duration of the trial.\n* FEV1 or DLCO (adjusted for hemoglobin) \\\u003C 50% of predicted.\n* Total bilirubin \\> 2x upper normal limit, except that potential subjects with Gilbert's Disease are permitted to exceed 2x upper normal limit.\n* ALT or AST \\> 2.5x upper normal limit.\n* Alkaline phosphatase \\> 2.5x upper normal limit, in conjunction with elevated GGT.\n* Albumin \\\u003C 3.0 g\u002Fdl.\n* Clinical evidence of sinusoidal obstruction syndrome.\n* Corrected creatinine clearance consistently \\\u003C 50 ml\u002Fmin\u002F1.73 m\\^2.\n* Clinically significant renal disease.\n* Hemolytic anemia.\n* Family history of catalase deficiency or history or evidence of a severe adverse reaction to hydrogen peroxide consistent with catalase deficiency, unless testing has demonstrated that the patient is not catalase-deficient.\n* Evidence of bone marrow insufficiency or failure, in the judgment of the investigator.\n* A hemoglobin \\\u003C 9 g\u002FdL.\n* G6PD deficiency as measured by quantitative enzyme levels below the normal reference range in blood.\n* Pre-existing bleeding diathesis or coagulopathy.\n* Potential subject is pregnant.\n* Breast feeding and unwilling to stop.\n* Wilson's disease.\n* Primary or secondary hemochromatosis.\n* Hgb A1c \\> 9%.\n* Hyperuricemia that is not responsive to therapy.\n* Plasma oxalate greater than 10 µM, which is not responsive to measures to reduce the level below 10 µM.\n* History of clinically significant elevation of plasma oxalic acid or complications related to oxalic acid.\n* Prior or current hepatitis B or C.\n* HIV infection or seropositivity for HIV.\n* Active, clinically significant bacterial, viral, or fungal infection.\n* History of colonization with a multidrug-resistant \"superbug\" that poses a high risk of an untreatable infection in the setting of neutropenia.\n* Uncontrolled seizure disorder.\n* If a potential subject has received radiation, then any of the following:\n\n  1. A volume ≥ 700 ml of normal liver received a dose ≥ 10 Gy.\n  2. The mean dose to normal liver (i.e., liver minus gross tumor volume) was ≥ 10 Gy.\n  3. The mean dose to normal lung (i.e., lung minus gross tumor volume) was ≥ 4 Gy.\n* History of significant allergy or other contraindication to BCNU, melphalan, vitamin B12b, vitamin C, pegfilgrastim, or Neupogen, or to any excipient in those drugs.\n* Use of any of the following cytochrome P450 2b6 (CYP2b6) inducers within 21 days of the planned date of BCNU treatment: phenobarbital, carbamazepam, rifampicin, phenytoin, sulfinpyrazone, or verapamil.\n* Disulfiram (Antabuse) use within 30 days of the planned ethanol administration.\n* Current chronic use of immunosuppressive agents (e.g., methotrexate, cyclosporine, corticosteroids).\n* Prior bone marrow stem cell transplant.\n* Except for adjuvant therapy for breast cancer or pancreatic cancer, prior radiation therapy to the brain, kidneys, pelvis, or GI tract or treatment with yttrium-90.\n* Prior treatment with bleomycin or BCNU.\n* Prior treatment, within 30 days of enrollment, with a drug that has not been FDA-approved for any indication (cancer or otherwise).\n* Subject has not fully recovered (i.e., there remain toxicities \\> Grade 1) from the reversible effects of prior chemotherapy, with the exception of chemotherapy-induced alopecia and grade 2 peripheral neuropathy, unless in the opinion of the principal investigator the effects are not of clinical significance.\n* Any concurrent anticancer treatment.\n* Serious underlying medical or psychiatric illness or another condition that in the clinical judgment of the principal investigator is likely to interfere with the potential subject completing participation in the trial, based on safety concerns or otherwise.\n* Inability or unwillingness to adhere to the study protocol.\n* Unwillingness to receive ethanol.",{"count":485,"type":21},24,[24],"The clinical trial is a phase 1, single-arm trial that will evaluate the safety of the investigational treatment on metastatic pancreatic cancer and metastatic breast cancer. The investigational treatment will involve 2 cycles of a combination of intravenous melphalan, BCNU, vitamin B12b, and vitamin C with autologous hematopoietic stem cell infusion. A dose-escalation schedule is being employed for the vitamin C.",[489,490,491,492,150,65,28,493,494,495,496,497,498,499,500,501,502,430,503,504],"Pancreatic Adenocarcinoma Metastatic","BRCA1 Mutation","BRCA2 Mutation","Pancreatic Acinar Cell Carcinoma","Metastatic Pancreatic Ductal Adenocarcinoma","Breast Cancer Metastatic","Breast Cancer Stage IV","Pancreatic Cancer Stage IV","HER2-negative Breast Cancer","HER2 Negative Breast Carcinoma","Adenocarcinoma of the Breast","PALB2 Gene Mutation","Pancreas Cancer, Metastatic","Pancreas Cancer, Recurrent","Stage IV Pancreatic Cancer","Stage 4 Pancreatic Cancer",[506,178,507,508,509,510,511,512,513,514,515,516,331,517,518,71,519,520,521,522,523,524,525,526,527,528],"pancreatic adenocarcinoma","BRCA","BRCA1","BRCA2","melphalan","BCNU","carmustine","vitamin C","vitamin B12b","autologous stem cell infusion","stage 4 pancreatic cancer","pancreatic acinar cell carcinoma","pancreatic ductal adenocarcinoma","breast cancer","stage 4 breast cancer","stage IV pancreatic cancer","stage IV breast cancer","stem cells","HER2-negative breast cancer","PALB2","metastatic breast cancer","BRCA pancreatic cancer","BRCA breast cancer","2026-01-27",{"date":467,"type":43},{"date":532,"type":43},"2021-01-13",{"date":534,"type":21},"2028-12",{"name":536,"class":83},"General Oncology, Inc.",{"id":538,"slug":4,"hasResults":11,"nctId":539,"briefTitle":540,"officialTitle":541,"acronym":4,"eligibilityCriteria":542,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":270,"enrollmentInfo":543,"targetDuration":4,"studyType":22,"phases":545,"briefSummary":546,"conditions":547,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":548,"lastUpdatePostDateStruct":549,"startDateStruct":551,"completionDateStruct":553,"leadSponsor":554,"locationsCount":104},"100589252","NCT06951997","QL1706 Plus Chidamide, AG as First-line Treatment for Metastatic Pancreatic Cancer","Clinical Study on the Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With Chidamide, Albumin-bound Paclitaxel and Gemcitabine as First-line Treatment for Metastatic Pancreatic Cancer","Inclusion Criteria:\n\n* Understand and voluntarily sign the informed consent form for this study\n* Age ≥18 years and ≤ 75 years, ale or Female\n* Histologically or cytologically confirmed diagnosis of pancreatic cancer (originating from the pancreatic ductal epithelium), with clinical records showing metastatic pancreatic cancer (stage IV according to the AJCC 8th edition TNM staging of pancreatic cancer)\n* No prior anti-tumor treatment (radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.) received\n* At least one measurable lesion on imaging according to RECIST 1.1\n* ECOG score 0-1\n* Expected survival time ≥3 months\n* Adequate organ function, subjects must meet the following laboratory criteria:Platelet count ≥90x10\\^9\u002FL,White blood cell count ≥ 3.5 × 10⁹\u002FL,Absolute neutrophil count (ANC) ≥1.5x10\\^9\u002FL,Hemoglobin \\> 90g\u002FL,Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN,Total bilirubin ≤ 1.5 ULN,Urea\u002FUrea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN (and creatinine clearance rate (CCr) ≥ 50 mL\u002Fmin),Left ventricular ejection fraction (LVEF) ≥ 50%,QTcF interval (Fridericia correction) \\\u003C 470 ms\n* Fertile women\u002Fnon-sterilized men must use effective contraception\n\nExclusion Criteria:\n\n* Inability to comply with the study protocol or procedures\n* patients with pancreatic cancer originating from non-pancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, pancreatic follicular cell carcinoma, pancreatoblastoma, and solid-pseudopapillary tumors\n* Known presence of germline BRCA1\u002F2 mutations\n* patients with known central nervous system metastases\n* Hypersensitivity or allergic predisposition to the study drug or its excipients\n* Concurrent use of any other investigational drug or participation in another clinical trial involving investigational therapy within 4 weeks\n* Major surgery, severe traumatic injury, fractures, or ulcers within 6 weeks before study\n* History of gastrointestinal perforation or fistula within 6 months before the first dose. Subjects may be enrolled if the perforation\u002Ffistula has been surgically repaired and the investigator confirms resolution\n* Clinically significant gastrointestinal disorders, including obstruction (including partial), dysphagia, malabsorption syndrome, or uncontrolled nausea, vomiting, diarrhea, or other conditions severely affecting nutrient absorption\n* Clinically significant bleeding or clear bleeding tendency within 1 month before the first dose, e.g.,gastrointestinal bleeding, hemorrhagic gastric ulcer\n* Any of the following concurrent conditions:(1) Uncontrolled hypertension, coronary artery disease, arrhythmia, or heart failure(2) Severe uncontrolled concurrent infection causing disability(3) Proteinuria ≥ 2+ (≥1.0 g\u002F24 h)(4) Bleeding tendency or history within 2 months before enrollment, regardless of severity(5) Arterial\u002Fvenous thromboembolic events within 12 months before treatment (e.g., cerebrovascular accident, transient ischemic attack)(6) Acute myocardial infarction, acute coronary syndrome, or CABG within 6 months before treatment(7) Unhealed fractures or chronic wounds(8) Coagulopathy, bleeding tendency, or ongoing anticoagulation therapy\n* History of other malignancies within 5 years before enrollment, except for adequately treated basal\u002Fsquamous cell skin cancer or cervical carcinoma in situ\n* Any cardiovascular or cerebrovascular disease or risk factors\n* Active autoimmune disease or history of autoimmune disease within 4 weeks before enrollment\n* Prior allogeneic bone marrow or solid organ transplantation\n* Unresolved toxicities (\\> CTCAE v5.0 Grade 1) from prior anticancer therapy, except alopecia, lymphopenia, and oxaliplatin-induced neurotoxicity (≤ Grade 2)\n* Prior treatment with immune checkpoint inhibitors (e.g., anti-PD-1\u002FPD-L1\u002FCTLA-4 antibodies), immune checkpoint agonists (e.g., anti-ICOS\u002FCD40\u002FCD137\u002FGITR\u002FOX40 antibodies), or immune cell therapy (e.g., CAR-T)\n* Systemic treatment with corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) or other immunosuppressants within 14 days before the first dose\n* Known interstitial lung disease (ILD) or non-infectious pneumonitis (either symptomatic or requiring systemic steroids)\n* Any other clinically significant condition, metabolic disorder, physical\u002Flab abnormality, epilepsy requiring treatment etal\n* Pregnant or breastfeeding women\n* Any other condition deemed unsuitable for study participation by the investigator",{"count":544,"type":21},33,[116],"This is a single-center, open-label, exploratory study aims to assess the efficacy and safety of QL1706 plus nab-paclitaxel and gemcitabine as first-line treatment for patients with metastatic pancreatic adenocarcinoma.",[28],"2026-01-22",{"date":550,"type":43},"2026-01-26",{"date":552,"type":43},"2025-03-07",{"date":161,"type":21},{"name":555,"class":136},"Tianjin Medical University Cancer Institute and Hospital",{"id":557,"slug":4,"hasResults":11,"nctId":558,"briefTitle":559,"officialTitle":560,"acronym":561,"eligibilityCriteria":562,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":563,"targetDuration":4,"studyType":22,"phases":565,"briefSummary":566,"conditions":567,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":568,"lastUpdatePostDateStruct":569,"startDateStruct":571,"completionDateStruct":573,"leadSponsor":575,"locationsCount":104},"100580918","NCT06843551","The Miami \"EMPIRE\" Trial - Eradication of Metastatic Pancreatic Cancer With Immuno-Radiation","A Phase 2 Single Arm Trial of Stereotactic Body Radiation Therapy Followed by Dual Immune Checkpoint Inhibition for Patients With Metastatic Pancreatic Ductal Adenocarcinoma - The Miami \"EMPIRE\" Trial - Eradication of Metastatic Pancreatic Cancer With Immuno-Radiation","EMPIRE","Inclusion Criteria:\n\n1. ≥18 years old\n2. Histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma.\n3. Microsatellite stable (MSS) disease by pathologic assessment.\n4. Patients must have measurable disease as defined by RECIST 1.1.\n5. Progression on ≥1 line of systemic therapy.\n6. No concomitant therapy with any of the following: interleukin (IL)-2, interferon, non study immunotherapy regimens, cytotoxic chemotherapy, immunosuppressive agents, other investigational therapies, and\u002For chronic use of systemic corticosteroids.\n7. No known infection with human immunodeficiency virus (HIV) or active infection with Hepatitis B.\n8. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n9. Life expectancy ≥3 months.\n10. Patients must have the following lab values obtained \\\u003C4 weeks prior to starting protocol treatment:\n\n    1. absolute neutrophil count (ANC) ≥1,000 cells\u002FμL\n    2. white blood count (WBC) ≥2,000 cells\u002FμL\n    3. platelets ≥75,000 per μL\n    4. hemoglobin ≥8.0 g\u002FdL\n    5. creatinine clearance ≥40 mL\u002Fmin)\n    6. serum total bilirubin ≤ 1.5 times the upper limit of normal (ULN)\n    7. aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤3 × ULN (or ≤5 × ULN in patients with liver metastases)\n    8. international normalized ratio or prothrombin time ≤1.5 × ULN\n    9. activated partial thromboplastin time ≤2.5 × ULN\n    10. absolute lymphocyte count (ALC) ≥1000 cells\u002FμL at baseline\n11. At least 1 previously unirradiated lesion amenable to pre-treatment biopsy.\n12. No limit on overall numbers of lesions, but liver tumor burden ≤25% of total liver volume.\n13. Women of childbearing potential (WOCBP): negative serum pregnancy test (within 7 days prior to Day 1 of protocol therapy)\n\n    a. Females of non-childbearing potential are defined as: i. ≥ 50 years of age and has not had menses for greater than 1 year ii. Amenorrheic for ≥ 2 years without a hysterectomy and bilateral oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon pre-study (screening) evaluation iii. Status is post-hysterectomy, bilateral oophorectomy, or tubal ligation.\n14. Male and female patients of reproductive potential must use effective methods of contraception or abstain from sexual activity for the course of the study through at least 6 months after the last dose of balstilimab and\u002For botensilimab. See Section 4.11, Contraception.\n\nExclusion Criteria:\n\n1. Liver tumor burden exceeding 25% of total liver volume.\n2. Active, untreated central nervous system (CNS) metastases.\n3. Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years of the start of study treatment (i.e., with use of disease-modifying agents or immunosuppressive drugs).\n4. Participants with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) within 14 days or another immunosuppressive medication within 30 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses (≤ 10 mg daily prednisone equivalent) are permitted in the absence of active autoimmune disease.\n5. Previous external beam radiation therapy to the liver or radioisotope therapy directed to the liver or any liver embolization.\n6. Clinically significant ascites requiring a paracentesis in the last 4 weeks, or clinically significant history of liver failure defined as any prior episode of hepatic encephalopathy and\u002For any prior history of an elevated serum ammonia level.\n7. Partial or complete bowel obstruction within the last 3 months prior to study enrollment, signs\u002Fsymptoms of bowel obstruction, or known radiologic evidence of impending obstruction.\n8. Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke or myocardial infarction within 6 months of study enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥ III), or serious uncontrolled cardiac arrhythmia requiring medication.\n\n   a. QT interval corrected using Fridericia's formula (QTcF) of \\> 480 ms.\n9. Prior allogeneic organ transplantation.\n10. Treatment with chemotherapy or targeted therapy within 2 weeks prior to initiating EMPIRE treatment.\n11. Persistent grade ≥2 adverse events (aEs) from prior therapy (except neuropathy).\n12. Known additional malignancy requiring active treatment.\n13. History of non-infectious pneumonitis.\n14. Active infection requiring antibiotic.\n15. Live vaccine within 30 days of protocol treatment.\n16. Severe acute respiratory syndrome (SARS) coronavirus 2 (CoV 2) (SARS-CoV-2) vaccine or booster \\\u003C 7 days before Cycle 1 Day 1 (C1D1). For vaccines requiring more than 1 dose, the full series should be completed prior to C1D1, when feasible. Booster shot not required but also must be administered \\> 7 days from C1D1 or \\> 7 days from future cycle on study.\n17. History of severe hypersensitivity reaction to monoclonal antibody.\n18. Participants with impaired decision-making capacity.",{"count":564,"type":21},20,[116],"The purpose of this study is to assess if radiation therapy (which uses high-energy radiation to damage or destroy cancer cells) combined with immune checkpoint inhibitors (medications that helps the body recognize and attack cancer cells) will be beneficial for patients with metastatic pancreatic ductal adenocarcinoma.",[493,28],"2025-08-12",{"date":570,"type":43},"2025-08-14",{"date":572,"type":43},"2025-06-18",{"date":574,"type":21},"2030-08-01",{"name":576,"class":136},"Benjamin Spieler",{"id":578,"slug":4,"hasResults":11,"nctId":579,"briefTitle":580,"officialTitle":581,"acronym":582,"eligibilityCriteria":583,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":584,"targetDuration":4,"studyType":22,"phases":586,"briefSummary":587,"conditions":588,"keywords":4,"overallStatus":307,"whyStopped":4,"lastUpdateSubmitDate":589,"lastUpdatePostDateStruct":590,"startDateStruct":592,"completionDateStruct":594,"leadSponsor":596,"locationsCount":4},"100431717","NCT04901741","Olaptesed With Pembrolizumab and Nanoliposomal Irinotecan or Gemcitabine\u002FNab-Paclitaxel in MSS Pancreatic Cancer","An Open-label Phase 2 Study of Olaptesed Pegol (NOX-A12) Combined With Pembrolizumab and Nanoliposomal Irinotecan\u002F5-FU\u002FLeucovorin or Gemcitabine\u002FNab-paclitaxel in Microsatellite-stable Metastatic Pancreatic Cancer Patients","OPTIMUS","Inclusion Criteria:\n\n* Patient with confirmed microsatellite-stable tumor pathology, if data available\n* Patient with histologically or cytologically confirmed primary metastatic adenocarcinoma of the pancreas, who\n\n  1. Arm 1: stopped first-line treatment with gemcitabine\u002Fnab-paclitaxel after documented objective radiographic progression OR\n  2. Arm 2: stopped first-line treatment with FOLFIRINOX or modified FOLFIRINOX after documented objective radiographic progression\n* Measurable disease based on RECIST 1.1 as determined by the investigational site\n* Estimated minimum life expectancy 3 months\n* Eastern Cooperative Oncology Group (ECOG) performance score 0 to 1\n* Adequate organ function laboratory values within the ranges specified: Serum albumin ≥ 3.0 g\u002FdL; Hematological system: Hemoglobin (Hb) ≥ 9.0 g\u002FdL or ≥5.6 mmol\u002FL, Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm³, Platelets ≥ 100,000\u002Fmm³; Renal system: Creatinine ≤ 1.5 x ULN OR eGFR ≥30 mL\u002Fmin for patient with creatinine levels \\>1.5 × institutional ULN; Hepatic system: Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ULN for patients with total bilirubin levels \\>1.5 × ULN, ALT and AST ≤ 2.5 x ULN (≤5 × ULN for patients with liver metastases); Coagulation: INR OR PT ≤ 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants, aPTT ≤ 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants\n\nExclusion Criteria:\n\n* Prior systemic anti-cancer therapy including investigational agents within 4 weeks or 5 half-lives, whichever is shorter, prior to treatment.\n* Patients must have recovered from all AEs due to previous therapies to ≤ Grade 1 or baseline. Patients with ≤ Grade 2 neuropathy may be eligible. Patients with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible.\n* If the patient had major surgery, the patient must have recovered adequately from the procedure and\u002For any complications from the surgery prior to starting study intervention\n* Prior radiotherapy within 2 weeks of start of study treatment. Patients must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.\n* Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137) and discontinued from that treatment due to a Grade 3 or higher irAE\n* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug\n* Received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention. Administration of killed vaccines are allowed\n* Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).\n* History of (non-infectious) pneumonitis \u002F interstitial lung disease that required steroids or current pneumonitis \u002F interstitial lung disease\n* Active infection requiring systemic therapy\n* Known additional malignancy that is progressing or has required active treatment within the past 2 years.\n* Known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n* Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment\n* Previous allogeneic tissue\u002Fsolid organ transplant",{"count":585,"type":21},60,[116],"The purpose of this study is to provide a go\u002Fno-go decision for a randomized expansion study by assessing the disease control rate (DCR) at 6 weeks for the combination of olaptesed pegol on top of pembrolizumab and (Arm 1) nanoliposomal irinotecan, 5-FU and leucovorin or (Arm 2) gemcitabine and nab-paclitaxel, to assess safety and tolerability and time-to-event endpoints.",[28],"2025-06-24",{"date":591,"type":43},"2025-06-27",{"date":593,"type":21},"2026-01",{"date":595,"type":21},"2029-03",{"name":597,"class":83},"TME Pharma AG",{"id":599,"slug":4,"hasResults":11,"nctId":600,"briefTitle":601,"officialTitle":601,"acronym":602,"eligibilityCriteria":603,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":604,"targetDuration":4,"studyType":22,"phases":606,"briefSummary":607,"conditions":608,"keywords":609,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":615,"startDateStruct":617,"completionDateStruct":619,"leadSponsor":621,"locationsCount":104},"100510492","NCT05927142","Combining Anti-PD-L1 Immune Checkpoint Inhibitor Durvalumab With TLR-3 Agonist Rintatolimod in Patients With Metastatic Pancreatic Ductal Adenocarcinoma for Therapy Efficacy","DURIPANC","Inclusion Criteria:\n\n* Histologically or cytologically (Bethesda 5 or 6) confirmed metastatic pancreatic cancer, as indicated by a definite cytology\u002Fhistology report.\n* Stable disease according to RECIST criteria version 1.1 after at least 8 cycles of chemotherapy (FOLFIRINOX).\n* Inclusion ≤ 6 weeks after stopping FOLFIRINOX.\n* An accessible metastatic lesion for histological tissue collection.\n* SIII\\\u003C900 (Systemic Immune-Inflammation Index = ((absolute neutrophil count \\* platelet count) \u002F absolute lymphocyte count)).\n* CA 19.9 \\\u003C1000kU\u002FL.\n* Age ≥ 18 years at time of study entry.\n* Body weight \\>30 kg.\n* WHO performance status of 0-1.\n* Adequate renal function (eGFR \\> 40 ml\u002Fmin).\n* Adequate liver tests (bilirubin ≤ 1.5 times normal; ALAT\u002FASAT ≤ 5 times normal).\n* Adequate bone marrow function (WBC \\> 3.0 x 109\u002FL, platelets \\> 75 x 109\u002FL, absolute neutrophil count (ANC) ≥1.0 × 109 \u002FL and hemoglobin \\> 5.6 mmol\u002FL.\n* Effective contraceptive methods.\n* Patient must have a life expectancy of at least 12 weeks.\n* Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (e.g., European Union Data Privacy Directive) obtained from the patient\u002Flegal representative prior to performing any protocol-related procedures, including screening evaluations.\n\nExclusion Criteria:\n\n* Child-Pugh Classification grade B\u002FC.\n* Current treatment with immunotherapeutic drugs.\n* Previous malignancy (excluding non-melanoma skin cancer, pancreatic neuroendocrine tumor (pNET) \\\u003C2cm, and gastrointestinal stromal tumor (GIST) \\\u003C2cm), unless no evidence of disease and diagnosed more than 3 years before diagnosis of pancreatic cancer, or with a life expectancy of more than 5 years from date of inclusion.\n* Malignant ascites or pleural effusion.\n* Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy.\n* Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n* An active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or other immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], diverticulitis \\[with the exception of diverticulosis\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\\]). The following are exceptions to this criterion:\n\nA. Patients with vitiligo or alopecia; B. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement; C. Any chronic skin condition that does not require systemic therapy; D. Patients without active disease in the last 5 years may be included but only after consultation with the study physician; E. Patients with celiac disease controlled by diet alone.\n\n* Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to the planned first dose of the study. The following are exceptions to this criterion: 1) Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection), 2) Systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or its equivalent and 3) Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).\n* Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP.\n* Prior randomization or treatment in a previous durvalumab clinical study regardless of treatment arm assignment.\n* Participation in another clinical study with an investigational product during the last 3 months.\n* Concurrent enrolment in another clinical study, unless it is an observational (noninterventional) clinical study or during the follow-up period of an interventional study.\n* Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies) ≤28 days prior to the first dose of study drug If sufficient wash-out time has not occurred due to the schedule or PK properties of an agent, a longer wash-out period will be required, as agreed by AstraZeneca and the investigator.\n* Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.\n\n  * Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.\n  * Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician.\n* Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.\n* Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug.\n* Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.\n* History of allogenic organ transplantation.\n* Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.\n* History of leptomeningeal carcinomatosis.\n* Brain metastases or spinal cord compression. Patients with suspected brain metastases at screening should have an MRI (preferred) or CT each preferably with IV contrast of the brain prior to study entry to rule out the presence of brain metastasis.\n* Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart).\n* Known active hepatitis infection, positive hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or HBV core antibody (anti-HBc), at screening. Participants with a past or resolved HBV infection (defined as the presence of anti HBc and absence of HBsAg) are eligible. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Adjust wording as necessary and consider evaluating at screening for studies with known hepatotoxicity or other relevant requirements.\n* Known to have tested positive for human immunodeficiency virus (HIV) (positive HIV 1\u002F2 antibodies) or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).\n* Serious concomitant systemic disorders that would compromise the safety of the patient or his\u002Fher ability to complete the study, at the discretion of the investigator.",{"count":605,"type":21},43,[24,116],"Pancreatic ductal adenocarcinoma (PDAC) is estimated to become the second leading cause of cancer-related death by 2030. Effective management of PDAC is challenged by a combination of late diagnosis, lack of effective screening methods and high risk of early metastasis. Although systemic chemotherapy improves survival, 5-year survival is only 6%. Chemotherapy efficacy is attenuated by innate and acquired drug resistance of tumor cells, a strong desmoplastic reaction that limits local accessibility of drugs and a \"cold\" tumor microenvironment (TME) with high infiltrating levels of immunosuppressive cells. In PDAC, increased T cell exhaustion defined by increased PD-1\u002FPD-L1 activity in both peripheral blood and tumor microenvironment, is associated with poor prognosis. Hence the rationale for targeting the PD-1\u002FPD-L1 axis with the aim to release the \"brake\" and exert an anti-tumor response. In PDAC successful results with Immune Checkpoint Inhibition (ICI) monotherapy are limited and combination therapy with other agents is encouraged; specifically agents that induce dendritic cell priming. We hypothesize that combination therapy of ICI therapy with a toll like receptor 3 (TLR-3) agonist is a potential effective strategy. TLR-3 agonists are hypothesized to increase dendritic cell maturation and cross-priming naïve cytotoxic CD8 T cells while eliminating regulatory T-cell attraction, thereby acting as an immune-boosting agent. We propose that rintatolimod\u002Fdurvalumab-combination therapy is feasible and may induce synergistic anti-tumor immune responses in PDAC.",[28],[610,611,612,613],"Immunotherapy","Pancreatic cancer","anti PD-L1","TLR-3 agonist","2025-02-24",{"date":616,"type":43},"2025-02-25",{"date":618,"type":43},"2024-01-09",{"date":620,"type":21},"2027-04",{"name":622,"class":136},"Joachim Aerts, MD PhD",{"id":624,"slug":4,"hasResults":11,"nctId":625,"briefTitle":626,"officialTitle":627,"acronym":4,"eligibilityCriteria":628,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":629,"targetDuration":4,"studyType":22,"phases":631,"briefSummary":632,"conditions":633,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":636,"lastUpdatePostDateStruct":637,"startDateStruct":639,"completionDateStruct":641,"leadSponsor":643,"locationsCount":104},"100576227","NCT06782555","A Study of Evofosfamide in Combination with Zalifrelimab and Balstilimab","A Phase 1\u002F2 Immunotherapy Study of Evofosfamide in Combination with Zalifrelimab and Balstilimab in Patients with Advanced Solid Malignancies","Inclusion Criteria:\n\n1. Histologically confirmed locally advanced or metastatic castration-resistant prostate cancer, pancreatic cancer, or HPV-negative SCCHN for which no other lines of standard therapy with demonstrated clinical benefit are available or appropriate as treatment.\n2. Appropriate to enter a clinical trial with a minimum estimated life expectancy of at least 3 months.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n4. Measurable disease as defined by RECIST 1.1. Patients with castration-resistant prostate cancer can have measurable or evaluable disease per PCWG3 criteria. Patients with evaluable disease must have documented evidence of PD as defined by any of the following:\n\n   * PSA progression: minimum of 2 rising values (3 measurements) obtained a minimum of 7 days apart with the last result being at least ≥4.0 ng\u002FmL.\n   * New or increasing non-bone disease per RECIST 1.1 criteria.\n   * Positive bone scan with 2 or more new lesions (PCWG3).\n5. Adequate bone marrow function as defined by the following laboratory test results obtained within 7 days of Cycle 1 Day 1:\n\n   * White blood cell count ≥2500 cells\u002Fmm3.\n   * Absolute neutrophil count ≥1500 cells\u002Fmm3.\n   * Absolute lymphocyte count \\>500 cells\u002Fmm3.\n   * Hemoglobin ≥9 g\u002FdL.\n   * Platelets ≥75,000 cells\u002Fmm3.\n6. Adequate liver function as defined by the following laboratory test results obtained within 7 days of Cycle 1 Day 1:\n\n   * Bilirubin ≤1.5 × institutional ULN; for patients with known Gilbert's syndrome, ≤3 × institutional ULN.\n   * Aspartate aminotransferase (SGOT) and alanine aminotransferase (SGPT) ≤3 × institutional ULN; if liver metastases are present, then ≤5 × ULN is allowed.\n7. At least 3 weeks from previous cytotoxic chemotherapy or radiation therapy and at least 5 half-lives or 6 weeks, whichever is shorter, from targeted or biologic therapy with the exception of CTLA-4, PD-1, or PD-L1 blocking antibodies for which only a 2 week interval is required. Patients with prostate cancer, unless they have undergone prior orchiectomy, may continue to receive androgen deprivation therapy, anti-androgen therapy, or therapy that interferes with androgenic stimulation.\n8. All patients must be willing to undergo a biopsy to provide a new tumor sample within 14 days of Cycle 1 Day 1. Patients who are unable to undergo a biopsy at screening must submit archival tumor tissue retrieved within the last 6 calendar months. Patients must also consent to undergo a biopsy between Day 15 of Cycle 2 and Day 8 of Cycle 3 in those subjects which it is clinically safe and attainable. A biopsy is not required for participants with metastatic prostate cancer with bone-only disease or inaccessible soft tissue lesions.\n9. Calculated creatinine clearance ≥ 60 mL\u002Fmin (by the Cockcroft Gault formula) within 7 days of Cycle 1 Day 1\n\nExclusion Criteria:\n\n1. A history of currently active\u002Funcontrolled autoimmune diseases or disorders, including inflammatory bowel disease (including Crohn's disease and ulcerative colitis), rheumatoid arthritis, systemic sclerosis (scleroderma), systemic lupus erythematosus, or autoimmune vasculitis (eg, Wegener's granulomatosis).\n2. Patients with prior history of any Grade 3 or Grade 4 AEs from anti-CTLA-4, anti-PD-1\u002FPD-L1, or anti-CTLA-4 and anti-PD-1\u002FPD-L-1 combination therapy.\n3. History of acute diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, abdominal carcinomatosis, or other known risk factors for bowel perforation.\n4. Patients on long-term systemic steroids (\\>10 mg daily prednisone equivalent initiated \\>2 weeks prior to study enrollment). Inhaled or topical steroids are permitted in the absence of active autoimmune disease.\n5. Any underlying medical or psychiatric condition, which in the opinion of the investigator, will make the administration of study treatment hazardous or obscure the interpretation of AEs, e.g., a condition associated with frequent diarrhea or chronic skin conditions, recent surgery (within 30 days) or colonic biopsy from which the patient has not recovered, partial endocrine organ deficiencies, or substance abuse.\n6. Concomitant use of QT-prolonging drugs with a risk of causing Torsades de Pointes (TdP).\n7. History of risk factors for TdP, including family history of long QT syndrome.\n8. Corrected QT (QTc) interval of ≥470 msec calculated according to Fridericia's formula (QTc=QT\u002FRR \\[0.33\\]).\n9. Sustained systolic blood pressure (BP) \\>140 mmHg or \\\u003C90 mmHg and sustained diastolic BP \\>100 mmHg or \\\u003C60 mmHg.\n10. Patients with newly diagnosed, uncontrolled and\u002For untreated cancer-related central nervous system disease. Patients with treated brain metastases that are radiographically or clinically stable for at least 2 weeks after therapy and have no evidence of cavitation or hemorrhage in the brain lesion(s) are eligible if they are asymptomatic and do not require corticosteroids (must have discontinued steroids at least 1 week prior to study enrollment).\n11. Uncontrolled intercurrent illness including, but not limited to, myocardial infarction within 6 months, unstable symptomatic ischemic heart disease, significant cardiac arrythmias, active uncontrolled infection requiring systemic therapy, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n12. Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks prior to study enrollment.\n13. Current evidence of active and uncontrolled infection, New York Heart Association Class III-IV chronic heart failure, documented Child's class B and C cirrhosis, active symptomatic pancreatitis, or uncontrolled medical disease which, in the opinion of the investigator, could compromise assessment of study treatment efficacy.\n14. Active human immunodeficiency virus infection (Exception: patients with well-controlled HIV \\[e.g., CD4 ≥ 350 cells\u002FuL and undetectable viral load\\] who have been on an effective (drug, dosage, and schedule associated with reduction and control of the viral load) antiretroviral therapy (ART) for ≥ 4 weeks are eligible). Patients with a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections in the last 12 months are not eligible. Note: Drug-drug interactions with ART occur via many mechanisms, with cytochrome P450 CYP3A4-mediated interactions being the most common. Patients who are using concurrent strong or moderate CYP3A4 inhibitors (e.g., ritonavir, cobicistat) or strong or moderate CYP3A4 inducers must be switched to an alternate effective ART regimen ≥ 4 weeks before study enrollment or should be excluded from the study if their regimen cannot be altered.\n15. Active or chronic hepatitis B or C virus infection. Patients with a history of HCV infection must have completed curative antiviral treatment and must have a viral load below the limit of quantification. A patient who is HCV Ab positive but HCV RNA negative due to prior treatment or natural resolution is eligible.\n16. Known hypersensitivity to any components of the study treatment or any of their excipients or analogs or drugs of similar chemical or biologic composition.\n17. Live vaccine within 4 weeks prior to study enrollment.\n18. Concomitant therapy with interleukin-2, interferon, or other non-study immunotherapy agents, or immunosuppressive agents.\n19. Concomitant use of strong or moderate inhibitors or strong or moderate inducers of CYP3A4 within 14 days or 5 half-lives (whichever is longer) prior to study enrollment and for the duration of study treatment.\n20. Concomitant use of anti-cancer chemotherapy, radiotherapy, hormone therapy, or targeted therapy. Patients with prostate cancer may continue treatment with anti-androgen and bone targeted therapies (e.g., zoledronic acid and denosumab). Palliative radiotherapy to nontarget lesions is permitted.",{"count":630,"type":21},71,[24,116],"The purpose of this Phase 1\u002F2 study is to test the overall safety, tolerability, and effectiveness of the combination investigational drugs evofosfamide, zalifrelimab, and balstilimab in treating advanced or metastatic castration-resistant prostate cancer, pancreatic cancer, and human papilloma virus (HPV)-negative squamous cell carcinoma of the head and neck (SCCHN).",[634,635,28],"Metastatic Prostate Cancer","Metastatic Head and Neck Squamous Cell Carcinoma","2025-01-17",{"date":638,"type":43},"2025-01-21",{"date":640,"type":43},"2025-01-08",{"date":642,"type":21},"2028-01",{"name":644,"class":83},"ImmunoGenesis",{"id":646,"slug":4,"hasResults":11,"nctId":647,"briefTitle":648,"officialTitle":649,"acronym":4,"eligibilityCriteria":650,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":270,"enrollmentInfo":651,"targetDuration":4,"studyType":22,"phases":653,"briefSummary":654,"conditions":655,"keywords":656,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":659,"lastUpdatePostDateStruct":660,"startDateStruct":662,"completionDateStruct":664,"leadSponsor":666,"locationsCount":668},"100574572","NCT06761027","mFOLFIRINOX Plus Anlotinib and Sintilimab for Advanced Pancreatic Cancer","mFOLFIRINOX Combined With Anlotinib and Sintilimab as First-Line Therapy for Locally Advanced or Metastatic Pancreatic Cancer: A Prospective, Single-arm, Multicenter, Phase Ib\u002FII Clinical Study","Inclusion Criteria:\n\n1. Fully understand this study and voluntarily sign the informed consent form;\n2. Age between 18 and 75 years inclusive, with no gender restrictions;\n3. Patients with locally advanced or metastatic pancreatic cancer diagnosed by histology or cytology;\n4. No prior anti-cancer treatment;\n5. Patients must have at least one measurable lesion (according to RECIST 1.1 criteria);\n6. ECOG PS score of 0-1;\n7. Expected survival of at least 3 months;\n8. No severe organic diseases of the heart, lungs, brain, liver, kidneys, or other organs;\n9. Women of childbearing age must agree to use contraceptive measures during the treatment period and for 6 months after the end of treatment; negative serum or urine pregnancy test within 7 days before study enrollment, and must be non-lactating, men must agree to use contraceptive measures during the study period and for 6 months after the study ends.\n\nExclusion Criteria:\n\n1. Have already received or are currently receiving additional anti-tumor treatment measures such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, or traditional Chinese medicine treatment;\n2. Known allergies to any of the drugs in the study;\n3. Symptomatic brain metastases or metastases with symptom control time less than 2 months;\n4. A large liver metastasis burden, occupying more than 70% of the liver volume;\n5. Patients with obstructive jaundice whose bilirubin cannot be reduced to the expected level after adequate decompression;\n6. Presence of any active autoimmune diseases or patients with autoimmune diseases expected to relapse (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes);\n7. History of immunodeficiency; patients currently using immunosuppressants, systemic corticosteroid therapy, or any other form of immunosuppressive treatment;\n8. Known genetic or acquired bleeding tendencies (such as coagulation disorders) or thrombosis, such as hemophiliacs; currently using or have recently (within 10 days before the start of the study treatment) used full-dose oral or injectable anticoagulants or thrombolytic drugs for therapeutic purposes (preventive use of low-dose aspirin, low molecular weight heparin is allowed);\n9. Serious infections (CTC AE greater than grade 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc.; baseline chest imaging suggests active pulmonary inflammation, presence of symptoms and signs of infection within 2 weeks before the first use of the study drug, or requiring oral or intravenous antibiotic treatment (excluding the use of antibiotics for prevention);\n10. History of other malignant tumors within the past 5 years or concurrently, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, and papillary thyroid carcinoma;\n11. Patients with mental illness; history of abuse of psychotropic drugs, alcoholism, and drug addiction;\n12. Pregnant or lactating women;\n13. Deemed by the investigator as unsuitable to participate in this trial for other reasons.",{"count":652,"type":21},29,[24,116],"This study is a prospective, single-arm, multicenter, phase Ib\u002FII clinical trial that treats previously untreated patients with locally advanced or metastatic pancreatic cancer using mFOLFIRINOX in combination with anlotinib and sintilimab. The purpose of this trial is to evaluate the efficacy and safety of this treatment regimen and to preliminarily explore the correlation between biomarkers and treatment outcomes.",[301,28],[657,658],"anlotinib","sintilimab","2025-01-04",{"date":661,"type":43},"2025-01-07",{"date":663,"type":43},"2024-12-23",{"date":665,"type":21},"2027-05",{"name":667,"class":136},"Fujian Provincial Hospital",4,{"id":670,"slug":4,"hasResults":11,"nctId":671,"briefTitle":672,"officialTitle":672,"acronym":673,"eligibilityCriteria":674,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":675,"targetDuration":4,"studyType":677,"phases":4,"briefSummary":678,"conditions":679,"keywords":4,"overallStatus":307,"whyStopped":4,"lastUpdateSubmitDate":680,"lastUpdatePostDateStruct":681,"startDateStruct":683,"completionDateStruct":685,"leadSponsor":687,"locationsCount":4},"100568976","NCT06688240","A Multi-center, Single-arm, Prospective Non-interventional Study to Investigate the Safety Profiles and Effectiveness of Liposomal Irinotecan (ONIVYDE®) in Combination with 5-fluorouracil (5-FU) and Leucovorin (LV) in Chinese Patients with Metastatic Pancreatic Cancer As Approval Condition (SEOPAC)","SEOPAC","Inclusion Criteria:\n\n* The adult patient (≥18 years of age) has given written informed consent to participate in the study.\n* The patient has been prescribed for ONIVYDE treatment according to the ONIVYDE China mainland SmPC.\n* Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas.\n* Documented metastatic disease.\n* Patient deemed not eligible or failed previous treatment with gemcitabine or gemcitabine containing therapy.\n\nExclusion Criteria:\n\n* Patients who have experienced a severe hypersensitivity reaction to ONIVYDE or Irinotecan HCL.\n* Patients with new or progressive dyspnea, cough, and fever, pending diagnostic evaluation or confirmed diagnostic of interstitial lung disease.\n* Pregnant or nursing (lactating) women.\n* Patients without highly effective methods of contraception during study treatment until 3 months after the last dose of the study drug, Specially,7 months for women of childbearing potential and 4 months for male with partners of childbearing potential after the last dose of the study drug.\n* Other additional exclusions may be applied by the investigator according to the contexts, in order to ensure that the study population will be non-interventional but representative of all eligible subjects.",{"count":676,"type":21},120,"OBSERVATIONAL","The aim of this phase 4 study is to evaluate the safety profile of ONIVYDE in China mainland.\n\nPrimary objective\n\nTo characterize the safety of ONIVYDE when used under standard clinical practice in China mainland on the following aspects:\n\n1. Quantify the rate of grade ≥3 neutropenia (primary objective)\n2. Serious adverse events and serious adverse drug reactions\n3. Adverse events and adverse drug reactions Secondary objective To describe effectiveness in patients receiving ONIVYDE in combination with 5-FU and leucovorin for the treatment of metastatic pancreatic cancer under standard clinical care in China mainland.\n\n(1) Overall survival (2) Overall response (3) Progression free survival (4) Quality of life assessment",[28],"2024-11-13",{"date":682,"type":43},"2024-11-14",{"date":684,"type":21},"2024-11",{"date":686,"type":21},"2027-07",{"name":688,"class":83},"Servier (Tianjin) Pharmaceutical Co. LTD.",""]