Neoadjuvant PD-L1 Inhibitor Plus Anlotinib for Kidney Preservation in Complex Renal Cell Carcinoma

NCT07602101 | Not Yet Recruiting Phase 2

• 1 other identifier: SPARE-KIDNEY
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective, multicenter, single-arm phase II study evaluating the efficacy and safety of neoadjuvant PD-L1 inhibitor TQB2450 in combination with anlotinib in patients with locally advanced, high-complexity (RENAL score ≥10) clear cell renal cell carcinoma (ccRCC). The primary objective is to determine whether neoadjuvant therapy can increase the rate of successful nephron-sparing surgery. In addition, this study incorporates a pre-specified translational research platform including circulating tumor DNA (ctDNA) methylation-based minimal residual disease (MRD) monitoring, tumor multi-omics profiling, and radiomics analysis. Artificial intelligence-based models will be developed to predict treatment response and surgical conversion, enabling precision neoadjuvant strategies.

Conditions

Clear Cell Renal Cell Carcinoma

Keywords

Clear Cell Renal Cell Carcinoma; Neoadjuvant Therapy; PD-L1; Anlotinib; Nephron-Sparing Surgery

Outcome Measures

Primary Outcomes (1)

• Rate of Successful Nephron-Sparing Surgery

  Defined as the proportion of patients who undergo partial nephrectomy

  At the time of surgery

Secondary Outcomes (5)

• MDT-Defined Conversion to Nephron-Sparing Surgery

  Pre-surgery

• Objective Response Rate (ORR)

  Pre-surgery

• Pathologic Complete Response (pCR)

  1 month after surgery

• Renal Function Preservation

  3 month after surgery

• Safety and Tolerability

  enrollment to 90 days after surgery

Other Outcomes (2)

• ctDNA methylation-based MRD dynamics across 4 time points

  enrollment to 90 days after surgery

• Tumor RNA expression and DNA methylation profiling

  enrollment to 90 days after surgery

Study Arms (1)

Neoadjuvant TQB2450 + Anlotinib

EXPERIMENTAL

Neoadjuvant TQB2450 + Anlotinib Drug: TQB2450 (PD-L1 inhibitor) 1200 mg intravenously every 3 weeks Drug: Anlotinib 12 mg orally once daily (2 weeks on, 1 week off) Treatment duration: 2-4 cycles prior to surgery

Drug: TQB2450 + Anlotinib

Interventions

TQB2450 + Anlotinib DRUG

Drug: TQB2450 (PD-L1 inhibitor) 1200 mg intravenously every 3 weeks Drug: Anlotinib 12 mg orally once daily (2 weeks on, 1 week off) Treatment duration: 2-4 cycles prior to surgery

Neoadjuvant TQB2450 + Anlotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• ECOG performance status 0-2
• Histologically confirmed clear cell renal cell carcinoma
• Clinical stage cT2-T3aN0M0 (AJCC 8th edition)
• RENAL nephrometry score ≥10
• Tumor assessed as requiring radical nephrectomy or complex partial nephrectomy
• Adequate organ function
• Signed informed consent

You may not qualify if:

• Prior systemic therapy for RCC (including ICIs or TKIs)
• Non-clear cell histology or sarcomatoid/rhabdoid differentiation \>20%
• Active autoimmune disease requiring systemic therapy
• Active uncontrolled infection (HBV/HCV/HIV)
• Prior organ transplantation
• Uncontrolled cardiovascular or pulmonary disease
• Pregnancy or breastfeeding

Sponsors & Collaborators

• RenJi Hospital: lead
• Huadong Hospital: collaborator
• Chinese PLA General Hospital: collaborator

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

anlotinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

jiwei huang

CONTACT

86-13651682825; huangjiwie@renji.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, multicenter, single-arm phase II study evaluating the efficacy and safety of neoadjuvant PD-L1 inhibitor TQB2450 in combination with anlotinib in patients with locally advanced, high-complexity (RENAL score ≥10) clear cell renal cell carcinoma (ccRCC).

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): May 31, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05