NCT07627464尚未招募2 期
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
Tianjin Medical University Cancer Institute and Hospital14 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2026年5月31日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 144
- 试验地点
- 14
研究概览
简要总结
Evaluation of long-term renal function improvement, surgical safety, as well as efficacy and safety of preoperative anlotinib hydrochloride capsules combined with benmelstobart injection versus surgery in patients with localized renal cell carcinoma undergoing partial nephrectomy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 75 years, inclusive.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •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.
- •No prior systemic therapy for renal cell carcinoma, including but not limited to targeted therapy, immunotherapy, investigational therapy, or hormone therapy.
排除标准
- •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.
研究者
研究点 (14)
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