Cardenilimab Combined With Lenvatinib in Patients With Perioperative Resectable Clear Cell Renal Cell Carcinoma.

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.

Timeline

Start

2024-09-01

Primary completion

2027-08-31

Completion

2027-09-01

Publications

• Results [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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Indications