Cardenilimab Combined With Lenvatinib in Patients With Perioperative Resectable Clear Cell Renal Cell Carcinoma.
NCT Number: NCT06574412
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Resectable Clear Cell Carcinoma of the Kidney
Interventions: DRUG: cardonilizumab combined with renvastinib
Sponsor: The First Hospital of Jilin University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2027-09-01

Summary:
This study is a single-arm, single-center, phase II clinical study. The main purpose is to evaluate the perioperative efficacy and safety of cardenilimab combined with lenvatinib in patients with resectable clear cell renal cell carcinoma. This study included a screening period, a treatment period, and a follow-up period. After completing the examination and assessment during the screening period, qualified subjects will enter the study treatment period after signing the informed consent form. Subjects should receive induction therapy and maintenance therapy in accordance with the protocol until there is disease progression on imaging as judged by the investigator based on RECIST 1.1 standards, intolerable toxicity, or the subject voluntarily requests to terminate study treatment or withdraws information. Agree, or the researcher determines that treatment needs to be terminated. (1) Primary research endpoint: Objective response rate (ORR) of primary tumor according to RECIST 1.1 criteria (2) Secondary research endpoint: 1. According to RECIST 1.1, as assessed by the investigator: (1) Progression-free survival (Progress Free Survival, PFS); (2) Overall survival (OS); 2. Type, incidence and severity of adverse events (AE) and serious adverse events (SAE) assessed in accordance with NCI-CTCAE 5.0 . 3. Pathological response rate (MPR), R0 resection rate 4. Based on Quality of Life QoL score.

Primary Outcome Measures: ObjectiveResponse Rate，ORR, Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR), The proportion of patients whose tumor size reduction reaches predetermined limits and persists over
Secondary Outcome Measures: Overall survival，OS, OS was defined as the time from the first study treatment to the date of death from any cause, The time from randomization to death (from any cause)|Progress Free Survival，PFS, PFS was defined as the time from randomization to tumor progression (any aspect) or death (from any cause)., The time between the start of randomization and the progression of tumor development (in any respect|Types, incidence, and severity of adverse event (AE), Classification per Common Terminology Criteria for Adverse Events (CTC-AE) version 5.0., 28 days after the last dose of study treatment|Types, incidence, and severity of serious adverse event (SAE), Classification per Common Terminology Criteria for Adverse Events (CTC-AE) version 5.0., 28 days after the last dose of study treatment|major pathologic response, MPR, After neoadjuvant therapy, the percentage of surviving tumor cells in the tumor bed was less than 10|After neoadjuvant therapy, the percentage of surviving tumor cells in the tumor bed was less than 10, Standard radical nephrectomy|Quality of life score, Classified according to EORTC QLQ-C30 (V3.0 Chinese Version)., 28 days after the last dose of study treatment