[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastric-adenocarcinoma-or-gastroesophageal-junction-adenocarcinoma-or-esophageal-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastric-adenocarcinoma-or-gastroesophageal-junction-adenocarcinoma-or-esophageal-carcinoma":97},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,72],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100592962",false,"NCT07000253","Timing of Minimally Invasive Local Treatment After First-Line Systemic Therapy in Oligometastatic Esophageal or Gastric Adenocarcinoma","Timing of Minimally Invasive Local Treatment After First-Line Systemic Therapy in Oligometastatic Esophageal or Gastric Adenocarcinoma: A Randomized Prospective Clinical Study (OMEC-5)","OMEC-5","Inclusion Criteria:\n\n* Age ≥18 years\n* Ability to provide written informed consent\n* Histologically confirmed esophageal, gastric or gastroesophageal junction tumor with oligometastatic (M1) disease defined according to the OMEC consensus statement:\n\n  * One organ with ≤3 metastases or 1 involved extra-regional lymph node station (based on the TNM 8 classification)\n  * ≤3 unilobar liver metastases or ≤2 bilobar liver metastases\n  * ≤ 3 unilateral lung metastases\n  * Unilateral adrenal gland involvement\n  * Metastasis confined to 1 bone structure or 1 soft tissue compartment\n* Synchronous oligometastatic disease with a resectable primary tumor or metachronous oligometastatic disease (in the event of a locoregional recurrence this should be resectable)\n* Metastases should be deemed amenable by the international multidisciplinary expert team for radical local treatment\n* WHO performance status 0-2\n* Indication for checkpoint inhibition and\u002For targeted therapy\n\n  * PD-L1 with a CPS of 1 or higher as per local clinical practice for immunotherapy use\n  * HER2 overexpression as per local clinical practice for trastuzumab use\n  * Claudin 18.2 overexpression as per local clinical practice for zolbetuximab use.\n  * Any other biomarker that allows targeted therapy in first line approved by EMA\n* No prior systemic therapy for metastatic disease\n* CT-scan ≤8 weeks prior to inclusion\n* Ability to undergo local treatment and start systemic treatment beyond 18 weeks of total systemic treatment.\n\nExclusion Criteria:\n\n* Squamous cell carcinoma\n* Brain metastases\n* Peritoneal or pleural carcinomatosis\n* Patients with MSI dMMR\n* Uncontrolled immunodeficiency (e.g. AIDS)\n* Peripheral neuropathy \\>CTCAE grade 1, precluding start of full dose oxaliplatin treatment\n* Both organ metastasis and extra-regional lymph node metastasis\n* Conditions precluding local treatment or systemic therapy for oligometastatic disease:\n\n  * Serious medical comorbidities precluding local treatment (e.g., interstitial lung disease in patients with pulmonary metastasis)\n  * Clinical or radiological evidence of spinal cord compression or epidural tumor within 2 mm of the spinal cord\n  * Simultaneous other malignancy or previous other malignancy with a disease-free period of \\\u003C5 years, except adequately treated non-melanoma skin cancer or in-situ cancers\n  * Uncontrolled (bacterial) infections\n  * Significant concomitant diseases preventing the safe administration of study drugs or likely to interfere with study assessments\n  * Uncontrolled angina pectoris, cardiac failure or clinically significant arrhythmias\n  * Continuous use of immunosuppressive agents equivalent to \\>10 mg daily prednisone\n  * Concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine\n  * Pregnancy or breast feeding\n  * Patients (M\u002FF) with reproductive potential not implementing adequate contraceptive measures","ALL","18 Years",{"count":19,"type":20},290,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE2","PHASE3","Purpose of the Study:\n\nThis clinical study investigates whether a shorter or longer duration of systemic therapy before local treatment (surgery or radiation) results in better disease control in patients with esophageal or gastric cancer with a limited number of metastases, also known as oligometastases.\n\nBackground:\n\nIn about 25% of patients with advanced esophageal or gastric cancer, the disease spreads to only a few sites (oligometastatic disease). Prior studies suggest that local treatment after systemic therapy may extend survival in this subgroup. However, it is unclear how long systemic therapy should last before initiating local treatment. The OMEC-5 study aims to clarify this and identify potential biomarkers for treatment response.\n\nStudy Design:\n\nInitiated by Amsterdam UMC and UMCU and conducted in multiple hospitals across Europe.\n\nTotal of 414 patients to be enrolled.\n\nDuration: \\~53 months (35 months enrollment + 18 months follow-up).\n\nApproved by the medical ethics committee at Amsterdam UMC.\n\nProcedure:\n\nEligibility screening: Includes physical exam, blood tests (incl. circulating tumor cells), medical history review, and confirmation of oligometastases by an expert panel.\n\nInitial treatment: All participants receive 4 months of standard systemic therapy (chemotherapy + immunotherapy and\u002For targeted therapy depending on tumor markers like HER2 or Claudin 18.2).\n\nResponse assessment (Review 1): Imaging and\u002For laparoscopic examination.\n\nIf oligometastases persist and tumors have not progressed, participants are randomized into two groups:\n\nGroup A (longer systemic therapy): 4 more months of systemic therapy, then local treatment if disease is stable, followed by 4 months of immunotherapy ± targeted therapy.\n\nGroup B (shorter systemic therapy): Immediate local treatment followed by 4 months of systemic therapy, then reassessment and potentially 4 months of immunotherapy ± targeted therapy.\n\nFollow-up: Regular scans and quality-of-life questionnaires (5 times), and periodic blood sampling (4 times).\n\nTreatments Involved:\n\nChemotherapy: CapOx or FOLFOX\n\nImmunotherapy: nivolumab or pembrolizumab\n\nTargeted therapy: trastuzumab (HER2-positive) or zolbetuximab (Claudin 18.2-positive)\n\nPotential Benefits and Risks:\n\nPatients may benefit from better disease control and a personalized treatment strategy.\n\nKnown side effects relate to the standard treatments used (chemo, immuno, targeted therapies), and no extra medical risk is expected beyond routine care.\n\nPossible inconveniences include blood draws, scans, minor surgery (laparoscopy), and time investment.\n\nData and Sample Handling:\n\nPersonal data and tumor\u002Fblood samples are coded and securely stored.\n\nData may be used for future cancer research if the patient consents.\n\nParticipants can withdraw at any time.\n\nConfidentiality and Privacy:\n\nPatient data are kept confidential, and participants have rights to access or delete their data. Privacy measures comply with GDPR and Dutch law.\n\nCompensation and Insurance:\n\nParticipation is voluntary, with no financial compensation. Standard treatment costs are covered by healthcare insurance. No extra insurance is required, as the treatment aligns with standard care practices.",[27,28,29,30,31,32],"Esophageal Cancer","Gastric (Stomach) Cancer","Gastric Adenocarcinoma","Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Carcinoma","Esophageal Carcinoma","Gastric (Cardia, Body) Cancer","RECRUITING","2026-05-03",{"date":36,"type":37},"2026-05-07","ACTUAL",{"date":39,"type":37},"2026-04-29",{"date":41,"type":20},"2034-01",{"name":43,"class":44},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",2,{"id":47,"slug":4,"hasResults":10,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":5},"100587867","NCT06933966","Evaluation of Efficacy and Safety De-escalation Versus Standard Adjuvant Chemotherapy in Patients With Low Risk Localized Gastroesophageal Adenocarcinoma","ATTENUATION - A Multicenter Randomized Phase II Study of the Efficacy and Safety De-escalation Versus Standard Adjuvant Chemotherapy in Patients With Low Risk Localized Gastroesophageal Adenocarcinoma (PRODIGE99\u002FFRENCH 39 Study)","ATTENUATION","Inclusion Criteria:\n\n* I1. Age ≥ 18 years, I2. Histologically proven non-metastatic (M0) gastric, oesophageal or gastroesophageal junction adenocarcinoma, I3. Subjects must have completed both pre-operative chemotherapy with a fluoropyrimidine-platinum containing regimen (FLOT 4 cycles) and microscopically complete (R0) resection prior to randomization.\n\nNote for surgery: total or distal gastrectomy with D2 lymphadenectomy according to ESMO guidelines should have been completed for gastric and junctional Siewert type III cancers. Ivor Lewis oesophagectomy with two field lymphadenectomy should have been performed for junctional Siewert type I cancers and lower oesophageal adenocarcinomas. For Siewert type II cancers either total gastrectomy with D2-lymphadenectomy or oesophagectomy with two field lymphadenectomy should have been completed. Open, minimal invasive or hybrid surgical approaches are acceptable as long as the requirements above are fulfilled. In frail patients with Siewert I or II, transhiatal oesophagectomy with lymphadenectomy in the lower mediastinum without transthoracic access is acceptable. Regardless of the type of surgery a minimum of 16 (gastric cancer) or 7 lymph nodes (in case of oesophageal carcinoma) should have been resected and examined (ref TNM 8 eme edition)\n\nI4. Low risk of disease recurrence, defined by the following criteria:\n\n* Absence of lymph node involvement (ypN0), assessed on a min. of 16 or 7 lymph nodes according to the localization and,\n* Either ypT0-2 (all TRG grade) or ypT3 (with TRG 1a-b according to Becker classification or TRG1-2 according to Mandard's classification), I5. ECOG Performance Status 0-1, I6. Patients fit to receive post-operative chemotherapy, I7. Interval between the date of surgery and the date of randomization no longer than 10 weeks, I8. Adequate organs function defined as : Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL; Platelets ≥ 100 x 109\u002FL; Haemoglobin ≥ 9 g\u002FdL (without transfusion within 7 days); Serum creatinine AND Calculated creatinine clearance as per MDRD or CKD-EPI formula ≤ 1.5 upper limit of normal (ULN) AND ≥ 40 mL\u002Fmin \u002F1.73m²; Serum total bilirubin ≤ 1.5 ULN OR Direct bilirubin ≤ ULN for patients with total bilirubin levels \\> 1.5 ULN (except for patients with Gilbert disease for whom a total serum bilirubin ≤ 3ULN is acceptable); AST and ALT ≤ 3 ULN; International Normalized Ratio (INR) and activated Partial Thromboplastin Time (aPTT)≤ 1.5 ULN .\n\nI9. No contraindication to study assessments, I10. Signed and dated informed consent for prior to any study-specific procedure, I11. Women of childbearing potential accepting to use highly effective contraceptive measures or abstain from heterosexual activity, for the course of the study and at least an- 9 months after the end of the treatment with oxaliplatin - 6 months after the end of the treatment with fluorouracil - 2 months after the end of the treatment with docetaxel and men must use contraception during treatment and at least - 6 months after the end of the treatment with oxaliplatin, - 3 months after the end of the treatment with fluorouracil - 4 months after the end of the treatment with docetaxel.\n\nI12. Patient must be covered by a medical insurance or equivalent.\n\nExclusion Criteria:\n\n* E1. Oesophageal squamous cell carcinomas, E2. Tumour with Deficient MisMatch Repair (MMR) and\u002For Microsatellite Instability status, E3. Dihydro Pyrimidine Dehydrogenase (DPD) deficiency, NB: if not previously done, the following blood chemistry level must be perform at screening, : blood uracil level - uracilemia dosing result is mandatory prior the inclusion E4. Persistent toxicities related to prior treatment of grade\\>1, E5. QTcF longer than 450 msec for men and longer than 470 msec for women, E6. Hypokalemia OR Hypomagnesemia OR Hypocalcemia Grade\\>1\n\nE7. Contraindication to postoperative treatment (FLOT):\n\n* Known history of hypersensitivity to fluorouracil, oxaliplatin, docetaxel or calcium folinate to any of their excipients, according to the SmPCs of these products OR\n* Peripheral sensory neuropathy with functional impairment prior to first treatment according the SmPC of oxaliplatin OR\n* Clinically significant active heart disease or myocardial infarction within 6 months OR\n* Recent or concomitant treatment with brivudine or recent treatment with live vaccines (minimal wash out period before randomisation: 4 weeks) E8. Any concurrent chemotherapy, Investigational product for cancer treatment. E9. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study E10. Suspicion of serious infection, E11. Pregnant or breastfeeding woman, E12. Patient under tutorship or curatorship of deprived of liberty.",{"count":54,"type":20},120,[23],"The ATTENUATION study targets patients with gastric adenocarcinoma (GA), esophageal adenocarcinoma (EAC) or gastro-esophageal junction (GEJ) who have received 4 cycles of FLOT chemotherapy before the surgery. Standard post-operative management consists of chemotherapy with 4 cycles of FLOT.\n\nHowever, the nature and duration of postoperative treatment are standardized and are not adapted to the specific tumor response of each patient. All patients are therefore referred to the same treatment regimen.\n\nAs a result, good responders (defined in particular by wide resection of the tumor and a good response to preoperative chemotherapy on the tumor removed during surgery) may be over-treated and exposed to unnecessary adverse events.\n\nOnly 50-60% of patients can start chemotherapy post-operatively, due to the potential residual adverse effects associated with surgery in particular. Thus, it would appear that preoperative chemotherapy is the most important factor in the overall efficacy of the treatment sequence. Moreover, numerous retrospective studies have reported a favorable outcome in patients with a major response to pre-operative treatment but who were unable to receive post-operative chemotherapy.\n\nThe hypothesis of this study is that surveillance after surgery in patients with gastric or gastroesophageal junction tumors, with a good response to preoperative chemotherapy could provide significant clinical benefit and favorable disease progression.\n\nParticipants will:\n\n* be distributed in one of the two arms\n* will be followed up every 3 months for 2 years, then every 6 months (clinical examination, imaging, quality-of-life questionnaire) subsequent years until 3 years after the randomization of the last patient.\n* followed up until their death or their progression whether local, regional or metastatic.",[30,58],"Non Metastatic Disease",[60,61],"De-escalation post-operative chemotherapy","Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Adenocarcinoma","NOT_YET_RECRUITING","2025-04-16",{"date":65,"type":37},"2025-04-18",{"date":67,"type":20},"2025-09-01",{"date":69,"type":20},"2032-09-01",{"name":71,"class":44},"Centre Leon Berard",{"id":73,"slug":4,"hasResults":10,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":4},"100586385","NCT06914687","Efficacy of Tirellizumab Combined With Oral, Intravenous and Abdominal Chemotherapy in Peritoneal Metastatic Gastric\u002FGastroesophageal Junction Adenocarcinoma","Tirellizumab Combined With SOX and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of Peritoneal Metastatic Gastric\u002FGastroesophageal Junction Adenocarcinoma: A Single-arm, Phase II Clinical Trial (Solids-03)","Inclusion Criteria:\n\nSigned informed consent Patients age 18-75 years Histologically CT\u002FMRI confirmed cT3-4NanyM1 gastric or GEJ adenocarcinoma; Peritoneal metastasis was confirmed by laparoscopy (with or without Krukenberg tumor ) The degree of peritoneal metastasis ≤P1b or PCI≤13 points ECOG 0-1, no surgery contraindications; Expected survival ≥3 months;\n\nExclusion Criteria:\n\nPrior chemotherapy, radiotherapy, surgery for gastric cancer; Signs of other distant metastases (e.g., liver, lung, bone, supraclavicular lymph, etc.) Significant cardiovascular disease Major surgical procedure within 4 weeks prior to initiation of study treatment Current treatment with anti-viral therapy or HBV Pregnancy or breastfeeding History of malignancy within 5 years prior to screening Present or history of any autoimmune disease or immune deficiency Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent There are active gastric and duodenal ulcers, ulcerative colitis and other gastrointestinal diseases, or active bleeding in unresectable tumors Poorly controlled hypertension or diabetes","75 Years",{"count":80,"type":20},30,[23],"For peritoneal metastatic gastric\u002Fgastroesophageal junction adenocarcinoma (cT3-4NanyM1), PD-1 antibody combined with chemotherapy and hyperthermic intraperitoneal chemotherapy (HIPEC) can downstage tumor stage, increase the conversion resection rate, and may improve the long-term survival. Tislelizumab, an anti-PD-1 antibody, has recently been proved in the first- and second-line standard treatment for advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma.In the subgroup analysis of RATIONALE-305 trial, tislelizumab also showed good efficacy in gastric\u002Fgastroesophageal junction adenocarcinoma patients with peritoneal metastasis. Combination of tirellizumab,SOX and HIPEC for peritoneal metastatic gastric\u002Fgastroesophageal junction adenocarcinoma could be a novel therapeutic strategy to increase response rate and therapeutic efficacy. This study is a monocenter, single-arm phase 2 clinical trial to evaluate tolerability, safety and efficacy of perioperative tirellizumab in combination with SOX and HIPEC in peritoneal metastatic gastric\u002Fgastroesophageal junction adenocarcinoma.",[29,30,84],"Peritoneal Metastasis",[86,84,87],"gastric cancer","Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma","2025-03-31",{"date":90,"type":37},"2025-04-06",{"date":92,"type":20},"2025-03-30",{"date":94,"type":20},"2028-04-01",{"name":96,"class":44},"Fudan University",""]