[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612641":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":18,"centralContacts":19,"locations":18,"responsibleParty":25,"collaborators":29,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":37,"acronym":18,"eligibilityCriteria":38,"healthyVolunteers":34,"sex":39,"minAge":40,"maxAge":18,"enrollmentInfo":41,"targetDuration":18,"studyType":44,"phases":45,"briefSummary":47,"conditions":48,"keywords":18,"overallStatus":51,"whyStopped":18,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":57,"leadSponsor":59,"locationsCount":18},{"fullName":5,"class":6},"Fudan University","OTHER",[8],{"label":9,"type":10,"description":9,"interventionNames":11},"Envafolimab+Lenvatinib","EXPERIMENTAL",[12],"Drug: Envafolimab+Lenvatinib",[14],{"type":15,"name":9,"description":16,"armGroupLabels":17,"otherNames":18},"DRUG","To evaluate the efficacy and safety of envafolimab in combination with lenvatinib for the treatment of patients with clear cell renal cell carcinoma (ccRCC) accompanied by liver metastases.",[9],null,[20],{"name":21,"role":22,"phone":23,"phoneExt":18,"email":24},"Dingwei Ye, MD","CONTACT","+862164175590","dwyeli@163.com",{"type":26,"investigatorFullName":27,"investigatorTitle":28,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Ding-Wei Ye","Director of Urology",[30],{"name":31,"class":6},"Huadong Hospital","100612641","phase-2-a-clinical-trial-of-envafolimab-combined-with-lenvatinib-for-kidney-cancer-with-liver-spread-100612641",false,"NCT07256223","A Clinical Trial of Envafolimab Combined With Lenvatinib for Kidney Cancer With Liver Spread","A Single-Arm, Multicenter, Prospective Clinical Study of Envafolimab Combined With Lenvatinib as First-Line Therapy in Renal Cell Carcinoma Patients With Liver Metastases","Inclusion Criteria:\n\nSubjects must meet all of the following criteria to be eligible for enrollment in the study:\n\nProvide written informed consent prior to any study-specific procedures.\n\nAged between 18 and 75 years, inclusive.\n\nHistologically confirmed clear cell renal cell carcinoma with radiologically documented liver metastases, and having received no prior systemic antitumor therapy.\n\nPresence of at least one measurable liver metastasis lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (with the longest diameter ≥ 10 mm on computed tomography scan for non-lymph node lesions).\n\nEastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n\nLife expectancy of ≥ 3 months.\n\nVoluntarily agree to participate in the study with good compliance.\n\nAdequate organ and bone marrow function, defined as follows:\n\nHematological:Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; Platelet count (PLT) ≥ 70 × 10⁹\u002FL; Hemoglobin (HGB) ≥ 90 g\u002FL.\n\nHepatic:Serum total bilirubin (TBIL) ≤ 1.5 × the upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN; Serum albumin ≥ 28 g\u002FL; Alkaline phosphatase (ALP) ≤ 5 × ULN. (Subjects who meet the above criteria after conventional liver-protecting therapy and remain stable for at least one week, as assessed by the investigator, may be enrolled.)\n\nRenal:Serum creatinine (Cr) ≤ 1.5 × ULN, or calculated creatinine clearance ≥ 50 mL\u002Fmin (using the standard Cockcroft-Gault formula).\n\nCoagulation:International normalized ratio (INR) ≤ 1.5 or prothrombin time (PT) ≤ 1.5 × ULN, and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN. (For subjects receiving anticoagulant therapy, enrollment is permitted if the PT and INR are within the therapeutic range intended by the anticoagulant medication.)\n\nExclusion Criteria:\n\nHistory of or concurrent other malignancies, except for appropriately treated carcinoma in situ or non-melanoma skin cancer with evidence of cure.\n\nPrior systemic antitumor therapy for advanced disease (including antiangiogenic agents and immunotherapy), with the exception of palliative radiotherapy or preoperative PD-1 neoadjuvant therapy.\n\nPresence of metastatic lesions meeting any of the following: unifocal organ metastasis numbering more than 3, or total systemic metastatic foci exceeding 5.\n\nKnown history of hypersensitivity to any component of the investigational drug products.\n\nPoorly controlled cardiac symptoms or diseases, including: (1) heart failure of New York Heart Association (NYHA) Class II or higher; (2) unstable angina pectoris; (3) myocardial infarction within the past year; (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.\n\nActive infection, or unexplained fever \\> 38.5°C occurring during the screening period or before the first dose (subjects with fever determined by the investigator to be tumor-related may be enrolled).\n\nAdministration of live vaccines within 4 weeks prior to the first dose of study treatment or anticipated during the study period.\n\nHistory of substance abuse, drug addiction, or chronic alcohol abuse.\n\nAny condition that, in the judgment of the investigator, would preclude participation in the study. This includes severe concomitant conditions (including psychiatric disorders) requiring treatment, significant laboratory abnormalities, or social\u002Ffamilial factors that could compromise subject safety or adherence to protocol requirements, including data and sample collection\n\n.\n\nActive hepatitis B infection.\n\nActive systemic autoimmune diseases.","ALL","18 Years",{"count":42,"type":43},30,"ESTIMATED","INTERVENTIONAL",[46],"PHASE2","This is an open-label, single-arm, prospective, multicenter clinical study designed to evaluate the efficacy and safety of envafolimab in combination with lenvatinib for the treatment of patients with clear cell renal cell carcinoma (ccRCC) accompanied by liver metastases. The Department of Urology at Fudan University Shanghai Cancer Center serves as the primary research center.",[49,50],"Clear Cell Renal Cell Cancer (ccRCC)","Liver Metastasis","NOT_YET_RECRUITING","2025-11-20",{"date":54,"type":55},"2025-12-01","ACTUAL",{"date":54,"type":43},{"date":58,"type":43},"2028-05-30",{"name":5,"class":6}]