[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cytoreductive-nephrectomy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cytoreductive-nephrectomy":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100537559","phase-2-upfront-immune-checkpoint-inhibitors-with-deferred-cytoreductive-nephrectomy-for-metastatic-renal-cell-carcinoma-100537559",false,"NCT06279403","Upfront Immune Checkpoint Inhibitors With Deferred Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma","Upfront Toripalimab Plus Axitinib Combined With Deferred Cytoreductive Nephrectomy for Metastatic Renal Cell Carcinoma","Inclusion Criteria:\n\nVoluntary consent to participate in this study and signing of an informed consent form.\n\nMale or female participants aged ≥18 years and \\\u003C80 years. Histologically diagnosed with clear cell carcinoma or predominantly clear cell renal cell carcinoma.\n\nClinical stage determined by CT or MRI: anyTN1M0 or anyTN0M1; IMDC score ≤3, or ≤5 metastatic lesions involving ≤3 organs; and the primary tumor (unilateral or bilateral) is resectable.\n\nECOG performance status: 0 or 1. No clinically significant cardiac, bone marrow, hepatic, or renal function abnormalities.\n\nA willingness and ability to comply with testing and follow-up procedures.\n\nExclusion Criteria:\n\nNon-clear cell carcinoma. Severe liver or kidney dysfunction, or other severe diseases. Immune deficiency, organ transplantation, or autoimmune diseases. Severe central nervous system diseases. Other malignant tumors within the past 5 years, except for cured basal cell carcinoma of the skin and cervical carcinoma in situ.\n\nUnable to comply with regular follow-up visits due to psychological, social, family, or geographical reasons.",true,"ALL","18 Years","80 Years",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Study Objective: To determine the efficacy of upfront immune checkpoint inhibitors combined with deferred cytoreductive nephrectomy in treating metastatic renal cell carcinoma.\n\nPrimary Endpoint: Pathological Major Response (MPR), defined as the percentage of residual tumor cells \\\u003C10% in the primary tumor after nephrectomy.\n\nStudy Design:\n\nPopulation: Participants meeting the diagnostic criteria with biopsy-proven clear cell renal cell carcinoma, IMDC score ≤3, or ≤5 metastatic lesions involving ≤3 organs.\n\nSample Size: 20 participants.\n\nPatient Grouping: Non-randomized.\n\nInterventions: Eligible participants will receive upfront treatment with a combination of Axitinib and Toripalimab for 4 cycles. After 2 cycles of treatment, radiological assessment will be conducted using RECIST 1.1 criteria. If disease progression is observed, the clinical trial will be terminated, and second-line treatment will be initiated according to guidelines. If disease progression is not observed, treatment will continue for 2 additional cycles followed by repeat radiological assessment before undergoing surgery.",[28,29,30],"Clear-cell Metastatic Renal Cell Carcinoma","Immune Checkpoint Inhibitors","Cytoreductive Nephrectomy","NOT_YET_RECRUITING","2024-02-25",{"date":34,"type":35},"2024-02-28","ACTUAL",{"date":37,"type":22},"2024-03-01",{"date":39,"type":22},"2029-03-01",{"name":41,"class":42},"RenJi Hospital","OTHER"]