[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"toripalimab\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:toripalimab":117},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,71,94],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100571395",false,"NCT06719700","Concurrent Chemoradiotherapy Combined With Toripalimab and Surufatinib in the Treatment of Limited-Stage Small Cell Lung Cancer","A Prospective Phase II Study of Concurrent Chemoradiotherapy Combined With Toripalimab and Surufatinib in the Treatment of Limited-Stage Small Cell Lung Cancer","Inclusion Criteria:\n\n* Informed Consent: An informed consent form, signed and dated, must be provided before any steps in the study are performed.\n* Age: Males or females aged 18 to 75 years.\n* Diagnosis: Histologically or cytologically confirmed small cell lung cancer (SCLC).\n* Stage: Stage I-III (AJCC\u002FUICC 8th edition TNM staging), where all lesions can be included in a single radical radiotherapy plan (i.e., limited-stage disease). Stage I-II must be inoperable.\n* Life Expectancy: ≥12 weeks.\n* Performance Status (PS): WHO PS score of 0 or 1.\n* Postmenopausal women or those with a negative urine or serum pregnancy test (HCG sensitivity ≥25 IU\u002FL or equivalent) within 7 days before starting study treatment.\n* Female participants must not be breastfeeding.\n* Women of childbearing potential (WOCBP) must agree to use contraception during study treatment and for 3 months after the last dose of study drug (i.e., 30 days for an ovulation cycle plus approximately 5 half-lives of the investigational drug).\n* Male participants engaging in sexual activity with WOCBP must agree to use contraception during study treatment and for 5 months after the last dose of study drug (i.e., 90 days for sperm regeneration cycle plus approximately 5 half-lives of the investigational drug).\n* Males with azoospermia do not need to follow contraception requirements.\n* WOCBP who are not sexually active do not need to follow contraception requirements but must still undergo pregnancy testing as outlined.\n* Organ and Bone Marrow Function:\n\nPulmonary Function: FEV1 ≥800 mL. Absolute neutrophil count ≥1.5 × 10⁹\u002FL. Platelet count ≥100 × 10⁹\u002FL. Hemoglobin ≥9.0 g\u002FdL. Renal Function: Calculated creatinine clearance ≥50 mL\u002Fmin using the Cockcroft-Gault formula.\n\nSerum bilirubin ≤1.5 × upper limit of normal (ULN). AST and ALT ≤2.5 × ULN.\n\nExclusion Criteria:\n\n* Participation in Another Clinical Trial: Simultaneous participation in another clinical trial, unless it is an observational (non-interventional) study.\n* Mixed Histology: Histological subtype of mixed small cell and non-small cell lung cancer (SCLC).\n* Extensive-Stage SCLC: Diagnosis of extensive-stage SCLC.\n* Malignant Effusions: Pathologically confirmed malignant pleural effusion or pericardial effusion.\n* Hemoptysis: Central cavitary SCLC with hemoptysis (hemoptysis volume \\>50 ml\u002Fday).\n* Immunosuppressive Treatment: Use of immunosuppressive drugs within 28 days prior to the first dose of toripalimab. Physiological doses of intranasal corticosteroids and systemic corticosteroids ≤10 mg daily of prednisone (or equivalent) are exceptions. Steroids used to manage chemoradiotherapy-related toxicities are allowed.\n* Previous Anti-PD-1\u002FPD-L1 Therapy: Prior use of any anti-PD-1 or anti-PD-L1 antibodies.\n* Major Surgery: Underwent major surgery (excluding vascular access) within 4 weeks before study entry.\n* Autoimmune Disease History: History of autoimmune diseases within the last 2 years, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis.\n* Primary Immunodeficiency: History of primary immunodeficiency.\n* Organ Transplant History: History of organ transplantation requiring immunosuppressive treatment.\n* QT Interval Prolongation: QTc interval (corrected by Bazett's formula) \\>470 ms, calculated from three ECG measurements.\n* Uncontrolled Comorbidities: Uncontrolled comorbid conditions, including but not limited to persistent or active infections, symptomatic congestive heart failure, poorly controlled hypertension, unstable angina, arrhythmias, active peptic ulcer disease or gastritis, active bleeding disorders, chronic hepatitis C, HIV infection, HBsAg-positive patients with DNA \\>500 IU\u002Fml, or any psychiatric or social conditions that may interfere with study requirements or the patient's ability to provide informed consent.\n* Tuberculosis History: Known history of tuberculosis.\n* Live Vaccination: Received a live attenuated vaccine within 30 days prior to study initiation.\n* Previous Primary Malignancy: History of another primary malignancy within 5 years prior to study entry, except for adequately treated basal or squamous cell carcinoma of the skin, in situ cervical cancer, ductal carcinoma in situ of the breast, or localized prostate cancer.\n* Pregnancy and Breastfeeding: Pregnant or breastfeeding women, or men and women of reproductive potential who are not using effective contraception.\n* Interference with Study Assessment: Any condition that may interfere with the evaluation of toripalimab's efficacy or safety.\n* Investigator's Discretion: Any other condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study.","ALL","18 Years","75 Years",{"count":19,"type":20},47,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Based on the preclinical rationale for combining surufatinib with immunotherapy, and the clinical efficacy observed with surufatinib in extensive-stage small cell lung cancer (ES-SCLC), the investigators hypothesize that incorporating surufatinib into the ADRIATIC regimen could further enhance survival in LS-SCLC. To evaluate this approach, the investigators plan to conduct a single-arm Phase II study to explore the safety and efficacy of concurrent chemoradiotherapy combined with toripalimab and surufatinib in treating LS-SCLC.",[26,27,28,29],"Toripalimab","Surufatinib","Chemoradiotherapy","Limited-stage Small Cell Lung Cancer (LS-SCLC)",[26,27,28,31,32],"Limited-stage small cell lung cancer (LS-SCLC)","Immunotherapy consolidation","RECRUITING","2026-02-28",{"date":36,"type":37},"2026-03-03","ACTUAL",{"date":39,"type":37},"2024-11-30",{"date":41,"type":20},"2028-11-29",{"name":43,"class":44},"Sun Yat-sen University","OTHER",1,{"id":47,"slug":4,"hasResults":10,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":10,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100616651","NCT07308379","Real-World Study of Toripalimab in Extensive-Stage Small Cell Lung Cancer","A Prospective, Observational, Multi-Center, Real-World Study of Toripalimab Injection in First-Line Treatment of Extensive-Stage Small Cell Lung Cancer","Inclusion Criteria:\n\n* Voluntarily participate and sign the informed consent form.\n* Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC);\n* Scheduled to receive Toripalimab as first-line treatment;\n* Availability of traceable medical history records during the treatment period.\n\nExclusion Criteria:\n\n* Pregnant or lactating women;\n* Known allergic to recombinant humanized anti-PD-1 monoclonal antibody drugs or their components；\n* Any other condition deemed by the investigator as unsuitable for inclusion in the study.",{"count":53,"type":20},1200,"OBSERVATIONAL","This is a prospective, observational, multi-center, real-world study evaluating the effectiveness and safety of Toripalimab (a PD-1 inhibitor) as first-line treatment for patients with extensive-stage small cell lung cancer (ES-SCLC). The primary objective is to assess real-world progression-free survival (rwPFS). Secondary objectives include evaluating real-world objective response rate (rwORR), disease control rate (rwDCR), overall survival (rwOS), and safety. Approximately 1200 patients from multiple centers in China will be enrolled and followed according to routine clinical practice. Data will be collected from medical records and follow-up visits.",[57,26],"SCLC, Extensive Stage",[59,26,60],"Extensive stage SCLC","Real-World Study","NOT_YET_RECRUITING","2025-12-15",{"date":64,"type":37},"2025-12-29",{"date":66,"type":20},"2026-02",{"date":68,"type":20},"2028-08",{"name":70,"class":44},"Fudan University",{"id":72,"slug":4,"hasResults":10,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":21,"phases":80,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":45},"100599590","NCT07086469","Surufatinib in Combination With Neoadjuvant Chemo-immunotherapy and Concurrent Chemoradiotherapy for Patients With Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma","A Prospective, Single-arm, Phase II Clinical Trial of Surufatinib in Combination With Neoadjuvant Chemo-immunotherapy and Concurrent Chemoradiotherapy for Patients With Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of esophageal squamous cell carcinoma (ESCC).\n* Locally advanced, unresectable esophageal cancer assessed by endoscopic ultrasound and imaging studies, including esophagography, contrast-enhanced CT scans of the lower neck, chest, and upper abdomen, MRI of the lower neck and chest, whole-body bone scintigraphy, or PET\u002FCT; staged as T2-4, N0-3, M0-1 (M1 limited to supraclavicular lymph node metastasis).\n* Male or female patients aged 18 to 80 years.\n* No prior chemotherapy, radiotherapy, surgery, targeted therapy, or immunotherapy.\n* Expected life expectancy of at least 12 weeks.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate organ and bone marrow function defined as: Forced expiratory volume in one second (FEV1) ≥ 1000 mL; Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; Platelet count ≥ 100 × 10⁹\u002FL; Hemoglobin ≥ 90 g\u002FL; Creatinine clearance ≥ 50 mL\u002Fmin calculated by the Cockcroft-Gault formula (Cockcroft and Gault, 1976); Total bilirubin ≤ 1.5 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN.\n* Signed and dated informed consent form must be obtained prior to any study-related procedures.\n\nExclusion Criteria:\n\n* Participation in another clinical trial simultaneously, except for observational (non-interventional) studies.\n* Prior use of any targeted therapy.\n* Major surgery within 4 weeks prior to study entry (excluding vascular access procedures).\n* Uncontrolled comorbidities, including but not limited to active or ongoing infections, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, arrhythmias, active peptic ulcer disease or gastritis, intestinal perforation, bowel obstruction, active bleeding disorders, or psychiatric\u002Fsocial conditions that may impair compliance with study requirements or the ability to provide informed consent.\n* Performance status (PS) score of 2-4.\n* Presence of any of the following organ or bone marrow dysfunctions: Forced expiratory volume in one second (FEV1) \\\u003C 1000 mL; Absolute neutrophil count (ANC) \\\u003C 1.5 × 10⁹\u002FL; Platelet count \\\u003C 100 × 10⁹\u002FL; Hemoglobin \\\u003C 90 g\u002FL; Creatinine clearance \\\u003C 50 mL\u002Fmin calculated by the Cockcroft-Gault formula (Cockcroft and Gault, 1976); Total bilirubin \\> 1.5 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\> 2.5 × ULN.\n* Any condition that may interfere with the assessment of efficacy or safety of surufatinib.","80 Years",{"count":79,"type":20},69,[23],"The combination of surufatinib with neoadjuvant chemo-immunotherapy and definitive concurrent chemoradiotherapy represents a promising new therapeutic strategy that may further improve the prognosis of patients with unresectable locally advanced esophageal squamous cell carcinoma (ESCC). Therefore, we propose to conduct a prospective, single-arm, phase II clinical trial to evaluate the efficacy and safety of this regimen in patients with unresectable, locally advanced ESCC.",[26,27,83,28,84],"Neoadjuvant Immunochemotherapy","Esophageal Squamous Cell Carcinoma",[26,27,83,28,84],"2025-11-13",{"date":88,"type":37},"2025-11-17",{"date":90,"type":37},"2025-07-20",{"date":92,"type":20},"2029-07-19",{"name":43,"class":44},{"id":95,"slug":4,"hasResults":10,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":21,"phases":102,"briefSummary":103,"conditions":104,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":45},"100383864","NCT04278222","Anlotinib Plus Toripalimab as First-line Treatment for Advanced Gastric Cancer With ECOG 2 (APICAL-GC)","Efficacy and Safety of Anlotinib Plus Toripalimab as First-line Regimen in Frail Patients (ECOG 2) With Advanced Gastric Cancer (APICAL-GC): an Open-label, Single Arm, Phase II Trial","Inclusion Criteria:\n\n* Histologically confirmed, UICC stage IV gastric cancer;\n* no prior systematic anti-cancer treatment and relapse or metastases was occurred more than 12 months after adjuvant chemotherapy;\n* at least one measurable lesion;\n* received radiotherapy 3 weeks before recruitment, but the lesion undergoing radiotherapy could not be used to calculate clinical benefit using RECISET criteria;\n* ECOG performance status 2;\n* the main organ function to meet the following criteria: HB ≥ 90g \u002F L, ANC ≥ 1.5 × 109 \u002F L, PLT ≥ 80 × 109 \u002F L,BIL \\\u003C1.5 times the upper limit of normal (ULN), ALT and AST \\\u003C2.5 × ULN and if liver metastases, BIL \\\u003C 3 × ULN, ALT and AST \\\u003C5 × ULN; Serum Cr ≤ 1.5 × ULN;\n* Patient's written declaration of consent obtained;\n* Estimated life expectancy \\> 3 months;\n\nExclusion Criteria:\n\n* harboring HER2 positive including IHC 3+ or IHC 2+ with Fish positive;\n* dMMR\u002FMSI-H;\n* Myocardial infarction, unstable angina pectoris, Grade III or IV heart failure (NYHA classification);\n* have received anlotinib or other immune checkpoint inhibitor ;\n* with known or clinically suspected brain metastases, autoimmune disease, organ transplantation ;\n* severe wounds or surgery 4 weeks before recruitment;\n* received glucocorticoid (more than 10mg prednisone ) and immunosuppressive agents;\n* History of a second malignancy during the past 5 years before inclusion in the study or during participation in the study, with the exception of a dermal basal cell or squamous cell carcinoma or cervical carcinoma in situ, if these were treated curatively.\n* pregnancy or breast feeding;\n* absent or restricted legal capacity;\n* a significant concomitant disease which, in the investigating physician's opinion, rules out the patient's participation in the study",{"count":101,"type":20},24,[23],"This study is designed to evaluate the efficacy and safety of the combination of Anlotinib wiht Toripalimab in advanced gastric cancer with ECOG 2 as first-line regimen.",[105,106,107,26],"Gastric Cancer","Immunotherapy","Anlotinib","2024-07-09",{"date":110,"type":37},"2024-07-10",{"date":112,"type":37},"2020-02-10",{"date":114,"type":20},"2024-12-31",{"name":116,"class":44},"Shanghai Changzheng Hospital",""]