Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma (RCC) | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anlotinib hydrochloride + Benmelstobart + Partial nephrectomy | Drug | — | UNRESOLVED |
| Partial nephrectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Anlotinib + Benmelstobart
- description
- 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
- interventionNames
- Drug: Anlotinib hydrochloride + Benmelstobart + Partial nephrectomy
- type
- ACTIVE_COMPARATOR
- label
- Upfront partial nephrectomy (standard care)
- description
- Patients receive upfront partial nephrectomy
- interventionNames
- Procedure: Partial nephrectomy
Primary outcomes (1)
- measure
- Pentafecta Achievement
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available