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NCT Number: NCT07627464

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

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Key information

Conditions

Renal Cell Carcinoma (RCC) Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking University Third Hospital, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anlotinib hydrochloride + Benmelstobart + Partial nephrectomy

Drug

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

partial nephrectomy

Procedure

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

Primary outcomes

  1. Pentafecta Achievement

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

    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.

Secondary outcomes

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

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

  2. Safety

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

    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

  3. 2-year DFS Rate

    Time frame: 2-years

    2-year Disease-Free Survival Rate

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

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

    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)

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Other

Registry information

Official study title

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

Acronym: ALTER-UC-011

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jun 4, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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