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

Phase 2Not Yet RecruitingNCT07627464

Tianjin Medical University Cancer Institute and Hospital144 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

144

Conditions

Renal Cell Carcinoma (RCC)

Interventions

Anlotinib hydrochloride + Benmelstobart + Partial nephrectomyDRUG

Patients receive neoadjuvant therapy with oral anlotinib hydrochloride capsules and intravenous benmelstobart injection, followed by partial nephrectomy for localized renal cell carcinoma.

Partial nephrectomyPROCEDURE

Patients receive upfront partial nephrectomy without neoadjuvant therapy, as the standard treatment for localized renal cell carcinoma.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (14)

Peking University Third Hospital

Beijing, China

Jilin Provincial Cancer Hospital

Changchun, China

Hunan Provincial Cancer Hospital

Changsha, China

Outcomes

Primary Outcomes

Pentafecta Achievement

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.

Time frame: Through study completion, an average of 1 year

Secondary Outcomes

Primary tumor partial response (PR) rate in the experimental arm

Time frame: Through study completion, an average of 1 year

Safety

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

Time frame: Through study completion, an average of 2 years

2-year DFS Rate

2-year Disease-Free Survival Rate

Time frame: 2-years

R.E.N.A.L. score changes in the experimental group

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)

Time frame: Through study completion, an average of 1 year

Data from ClinicalTrials.gov

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