Anlotinib + Benmelstobart vs Surgery for Patients With Localized Renal Cell Carcinoma Scheduled to Undergo Partial Nephrectomy (ALTER-UC-011)
A Multicenter, Randomized Controlled Phase II Study of Neoadjuvant Anlotinib Hydrochloride Capsules Combined With Benmelstobart Injection Versus Surgery Alone for Localized Renal Cell Carcinoma Planned for Partial Nephrectomy
研究概览
地位
条件
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习地点
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Beijing、中国
- Peking University Third Hospital
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接触：
- Shudong Zhang
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Changchun、中国
- Jilin Provincial Cancer Hospital
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接触：
- Changdong Zhou
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Changsha、中国
- Hunan Provincial Cancer Hospital
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接触：
- Xie Yu
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Hangzhou、中国
- The First Affiliated Hospital, Zhejiang University School of Medicine
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接触：
- Dan Xia
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Kunming、中国
- Yunnan Provincial Cancer Hospital
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接触：
- Yong Yang
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Nanjing、中国
- Nanjing Drum Tower Hospital
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接触：
- Hongqian Guo
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Nanning、中国
- The First Affiliated Hospital of Guangxi Medical University
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接触：
- Jiwen Chen
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Qingdao、中国
- The Affiliated Hospital of Qingdao University
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接触：
- Ke Wang
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Shanghai、中国
- Huadong Hospital affiliated to Fudan University
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接触：
- Hailiang Zhang
- 电话号码：+86135 2407 1783
- 邮箱：zhanghl918@163.com
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Shenyang、中国
- Liaoning Provincial Cancer Hospital
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接触：
- Bing Hu
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Taiyuan、中国
- Shanxi Province Cancer Hospital
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接触：
- Xuebing Han
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Tianjin、中国
- Tianjin Medical University Cancer Institute and Hospital
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接触：
- Yao Xin, Ph.D.
- 电话号码：+86-02223340123
- 邮箱：yaoxin@tjmuch.com
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Wuhan、中国
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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接触：
- Xiaoping Zhang
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Zhengzhou、中国
- The First Affiliated Hospital of Zhengzhou University
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接触：
- Xuepei Zhang
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Aged between 18 and 75 years, inclusive.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Subjects with newly diagnosed cT1bN0M0 renal cell carcinoma (RCC) scheduled to undergo partial nephrectomy.
- Have at least one measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- No prior systemic therapy for renal cell carcinoma, including but not limited to targeted therapy, immunotherapy, investigational therapy, or hormone therapy.
Exclusion Criteria:
- Subjects with a solitary kidney tumor.
- Subjects with bilateral renal tumors or unilateral multiple renal tumors (n ≥ 2).
- Subjects with hereditary or familial renal tumors (e.g., von Hippel-Lindau [VHL] disease).
- Subjects with a prior history of renal transplantation.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Anlotinib + Benmelstobart
Anlotinib capsules 12 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)； Benmelstobart 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle
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Patients receive neoadjuvant therapy with oral anlotinib hydrochloride capsules and intravenous benmelstobart injection, followed by partial nephrectomy for localized renal cell carcinoma.
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有源比较器：Upfront partial nephrectomy (standard care)
Patients receive upfront partial nephrectomy
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Patients receive upfront partial nephrectomy without neoadjuvant therapy, as the standard treatment for localized renal cell carcinoma.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pentafecta Achievement
大体时间：Through study completion, an average of 1 year
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It includes: negative surgical margin, warm ischemia time (WIT) ≤ 25 minutes, no perioperative complications, estimated glomerular filtration rate (eGFR) preservation ≥ 90% at 9-12 months postoperatively, and no increase in chronic kidney disease (CKD) stage at 9-12 months postoperatively. The eGFR preservation rate is calculated as the percentage of the postoperative eGFR relative to the preoperative baseline eGFR. An increase in CKD stage is defined as progression to Stage III, IV, or V; progression from Stage I to Stage II is not considered an increase in CKD stage. |
Through study completion, an average of 1 year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Primary tumor partial response (PR) rate in the experimental arm
大体时间：Through study completion, an average of 1 year
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Through study completion, an average of 1 year
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Safety
大体时间：Through study completion, an average of 2 years
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Number of participants with treatment-related adverse events as assessed by CTCAE 6.0 To further describe safety and assess toxicities encountered with the use of the proposed treatment regimen in participants
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Through study completion, an average of 2 years
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2-year DFS Rate
大体时间：2-years
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2-year Disease-Free Survival Rate
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2-years
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R.E.N.A.L. score changes in the experimental group
大体时间：Through study completion, an average of 1 year
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The R.E.N.A.L. Nephrometry Score is a 4-12 point anatomical classification system for renal tumors, with each letter representing a key feature scored as 1, 2, or 3 points, as follows: (R) Radius (Maximum tumor diameter, cm)； (E) Exophytic/endophytic properties (Tumor growth pattern)； (N) Nearness to the collecting system or renal sinus (Tumor distance to collecting system/renal sinus, mm)； (A) Anterior/posterior location； (L) Location relative to the polar line (Relationship to renal polar line; suffix (h) is added if the tumor is adjacent to major renal artery or vein) |
Through study completion, an average of 1 year
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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