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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant -surgery-adjuvant therapy group | Experimental | Preoperative: Cardenilimab was administered at a dose of 10 mg/kg intravenously once daily, with one cycle every 21 days, for a total of 4 cycles. Lenvatinib was prescribed as follows: for patients weighing less than 60 kg, 8 mg was given orally once daily for 4 cycles; for those weighing more than 60 kg, 12 mg was administered orally once daily for a total of 4 cycles. Surgery: The patient underwent standard radical nephrectomy 30 to 40 days after completing the 4 cycles of lenvatinib treatment. Postoperative: Cardenilimab was continued at a dose of 10 mg/kg intravenously once daily, with one cycle every 21 days, for a total of 8 cycles. Lenvatinib dosing postoperatively was as follows: for patients weighing less than 60 kg, 8 mg was given orally once daily for a total of 8 cycles; for those weighing more than 60 kg, 12 mg was administered orally once daily for a total of 8 cycles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cardonilizumab combined with renvastinib | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | [1] Siegel RL, Miller KD, Jemal A: Cancer statistics, 20182018;68: 7-30. [2] 赫捷.2018 中国肿瘤登记年报[M].北京:人民卫生出 版社,2019:129 [3] Motzer RJ, Hutson TE, Tomczak P, et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma [J]. N Engl J Med, 2007, 356(2): 115-124. [4] Escudier B, Szczylik C, Hutson T E, et al. Randomized phase II trial of first-line treatment with sorafenib versus interferon Alfa-2a in patients with metastatic renal cell carcinoma [J]. Journal of clinical oncology, 2009, 27(8): 1280-1289. [5] Motzer R J, Hutson T E, Tomczak P, et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma [J]. New England Journal of Medicine, 2007, 356(2): 115-24. [6] 韩雪冰.靶向联合免疫治疗提高晚期肾癌疗效[J].健康向导,2023,29(01):15. [7] 张凯,朱刚.2020 版 EAU 肾细胞癌诊疗指南更新解读 之二[J].中华泌尿外科杂 2020, 41( 8) : 578-580. [8] 邓 建 华 , 纪 志 刚 . 高 危 肾 细 胞 癌 术 前 新 辅 助 靶 向 药 物 治 疗 [J]. 现 代 泌 尿 外 科 杂 志,2018,23(06):405-408. [9] 李凡,管维.肾癌诊疗相关进展[J].临床外科杂志,2021,29(02):101-104. [10] Bex A, van Thienen JV, Schrier M, et al. A Phase II, single-arm trial of neoadjuvant axitinib plus avelumab in patients with localized renal cell carcinoma who are at high risk of relapse after nephrectomy (NEOAVAX) [published correction appears in Future Oncol. 2019 Aug;15(22):2667]. Future Oncol. 2019;15(19):2203-2209. [11] Karam JA, Msaouel P, Haymaker CL, Matin SF, Campbell MT, Zurita AJ, Shah AY, Wistuba II, Marmonti E, Duose DY, Parra ER, Soto LMS, Laberiano-Fernandez C, Lozano M, Abraham A, Hallin M, Chin CD, Olson P, Der-Torossian H, Yan X, Tannir NM, Wood CG. Phase II trial of neoadjuvant sitravatinib plus nivolumab in patients undergoing nephrectomy for locally advanced clear cell renal cell carcinoma. Nat Commun. 2023 May 10;14(1):2684. |
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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 |