[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"surufatinib\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:surufatinib":96},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,69],{"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":16,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"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":54,"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.",[26,27,58,28,59],"Neoadjuvant Immunochemotherapy","Esophageal Squamous Cell Carcinoma",[26,27,58,28,59],"2025-11-13",{"date":63,"type":37},"2025-11-17",{"date":65,"type":37},"2025-07-20",{"date":67,"type":20},"2029-07-19",{"name":43,"class":44},{"id":70,"slug":4,"hasResults":10,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":77,"briefSummary":78,"conditions":79,"keywords":84,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":94,"leadSponsor":95,"locationsCount":45},"100599589","NCT07086456","Combination of Concurrent Chemoradiotherapy With Surufatinib and Tislelizumab in Patients With Locally Advanced Non-Small Cell Lung Cancer","Evaluating the Combination of Concurrent Chemoradiotherapy With Surufatinib and Tislelizumab in Patients With Locally Advanced Non-Small Cell Lung Cancer: A Prospective, Single-Arm Phase II Clinical Trial","Inclusion Criteria:\n\n* A written and dated informed consent form must be obtained prior to the initiation of any study-specific procedures.\n* Male or female patients aged 18 to 75 years.\n* Histologically or cytologically confirmed locally advanced, unresectable non-small cell lung cancer (NSCLC) (Stage IIIA-IIIC).\n* Tumor sample requirement: Adequate archival, unstained tumor tissue samples must be provided for analysis.\n* Expected life expectancy of ≥12 weeks.\n* World Health Organization (WHO) performance status (PS) score of 0 or 1.\n* Postmenopausal women, or negative urine or serum pregnancy test (with a minimum sensitivity of 25 IU\u002FL or equivalent for HCG) within 14 days prior to receiving study medication.\n* Female participants must not be breastfeeding.\n* Women of childbearing potential (WOCBP) must agree to use effective contraception during the study treatment period and for 6 months after the last dose of study drug.\n* Male participants who are sexually active with WOCBP must agree to use effective contraception during the study treatment period and for 6 months after the last dose of study drug.\n* Male participants with azoospermia are exempt from contraceptive requirements. WOCBP who are not heterosexually active are also exempt from contraceptive use but must still undergo pregnancy testing as specified above.\n* Adequate organ and bone marrow function as defined by the following criteria: Forced expiratory volume in 1 second (FEV1) ≥ 800 mL; Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; Platelet count ≥ 100 × 10⁹\u002FL; Hemoglobin ≥ 9.0 g\u002FdL; Serum creatinine clearance ≥ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula; Cockcroft and Gault, 1976); Total serum bilirubin ≤ 1.5 × upper limit of normal (ULN); AST and ALT ≤ 2.5 × ULN\n\nExclusion Criteria:\n\n* Participation in another clinical study, unless it is an observational (non-interventional) study.\n* Histological diagnosis of combined small cell and non-small cell lung cancer.\n* Presence of EGFR or ALK driver gene mutations.\n* Any condition that may affect oral medication administration (e.g., dysphagia, chronic diarrhea, bowel obstruction).\n* Major surgery within 4 weeks prior to study entry (excluding vascular access procedures).\n* Average QT interval corrected for heart rate (QTc) ≥ 470 ms, calculated using Bazett's formula from three ECG cycles.\n* Uncontrolled comorbidities, including but not limited to: ongoing or active infections, symptomatic congestive heart failure, poorly controlled hypertension, unstable angina, clinically significant arrhythmias, active peptic ulcer disease or gastritis, active bleeding disorders, or patients who are HBsAg-positive with HBV DNA \\> 500 IU\u002FmL, hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection. Also excluded are individuals with psychiatric or social conditions that may interfere with study compliance or the ability to provide written informed consent.\n* History of another primary malignancy within 5 years prior to study treatment initiation, except for adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.\n* Pregnant or breastfeeding women; or women and men of reproductive potential who are not using effective contraception.\n* Use of immunosuppressive medications within 28 days prior to the first dose of tislelizumab, excluding intranasal corticosteroids at physiological doses and systemic corticosteroids at a dose equivalent to ≤10 mg\u002Fday of prednisone.\n* History of autoimmune disease or active autoimmune disease within the past 2 years.\n* Active or prior history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).\n* History of primary immunodeficiency.\n* History of organ transplantation requiring immunosuppressive therapy.\n* Receipt of a live attenuated vaccine within 30 days prior to study initiation or within 30 days after receiving tislelizumab.\n* Any condition that, in the investigator's judgment, may interfere with the assessment of efficacy or safety of the study treatment.",{"count":76,"type":20},80,[23],"This is a prospective, single-arm, phase II clinical study designed to evaluate the efficacy and safety of surufatinib and tislelizumab in combination with concurrent chemoradiotherapy, followed by consolidation therapy with tislelizumab plus surufatinib, in patients with unresectable, locally advanced stage III non-small cell lung cancer (NSCLC).",[27,80,81,82,83],"Tislelizumab","Concurrent Chemoradiotherapy","Consolidation Therapy","Non-small Cell Lung Cancer",[85,86,87,88,89],"surufatinib","tislelizumab","concurrent chemoradiotherapy","consolidation therapy","non-small cell lung cancer","2025-07-24",{"date":92,"type":37},"2025-07-25",{"date":65,"type":20},{"date":67,"type":20},{"name":43,"class":44},""]