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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Preoperative: Cardenilimab: 10 mg/kg qd intravenously, one cycle every 21 days, administered on the first day of each cycle, a total of 4 cycles. Lenvatinib: Weight \<60kg, 8mg, once a day, orally, for 4 cycles Weight \>60kg, 12mg, once a day, orally, for a total of 4 cycles Surgery: The patient is receiving 4 cycles of cardenilimab + Standard radical nephrectomy was performed within 30-40 days after the end of lenvatinib treatment. Postoperative: Cardenilimab: 10 mg/kg qd intravenously, 1 cycle every 21 days, administered on the 1st day of each cycle, a total of 8 cycles Lenvatinib: body weight \<60 kg, 8 mg, once a day, orally , a total of 8 cycles, weight \> 60kg, 12mg, once a day, orally, a total of 8 cycles.
ObjectiveResponse Rate,ORR
Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)
Time frame: The proportion of patients whose tumor size reduction reaches predetermined limits and persists over
Overall survival,OS
OS was defined as the time from the first study treatment to the date of death from any cause
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 28 days after the last dose of study treatment
major pathologic response, MPR
Time frame: 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
Time frame: Standard radical nephrectomy
Quality of life score
Classified according to EORTC QLQ-C30 (V3.0 Chinese Version).
Time frame: 28 days after the last dose of study treatment
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