Anlotinib + Benmelstobart vs Surgery for Patients With Localized Renal Cell Carcinoma Scheduled to Undergo Partial Nephrectomy

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

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

Inclusion Criteria:

1. Aged between 18 and 75 years, inclusive.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
3. Subjects with newly diagnosed cT1bN0M0 renal cell carcinoma (RCC) scheduled to undergo partial nephrectomy.
4. Have at least one measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
5. No prior systemic therapy for renal cell carcinoma, including but not limited to targeted therapy, immunotherapy, investigational therapy, or hormone therapy.

Exclusion Criteria:

1. Subjects with a solitary kidney tumor.
2. Subjects with bilateral renal tumors or unilateral multiple renal tumors (n ≥ 2).
3. Subjects with hereditary or familial renal tumors (e.g., von Hippel-Lindau [VHL] disease).
4. Subjects with a prior history of renal transplantation.