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.
• Age ≥18 years
ECOG performance status 0-2
Histologically confirmed clear cell renal cell carcinoma
Clinical stage cT2-T3aN0M0 (AJCC 8th edition)
• 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)
Single group
TQB2450 + Anlotinib
DrugDrug: 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
Rate of Successful Nephron-Sparing Surgery
Defined as the proportion of patients who undergo partial nephrectomy
MDT-Defined Conversion to Nephron-Sparing Surgery
o Defined as conversion from pre-treatment planned radical nephrectomy or complex partial nephrectomy to post-treatment feasibility of standard or simplified partial nephrectomy；o Determined by a centrally reviewed multidisciplinary team based on imaging
Objective Response Rate (ORR)
Assessed by RECIST v1.1
Pathologic Complete Response (pCR)
Pathologic Complete Response (pCR) after surgery
Renal Function Preservation
Proportion of patients with ≤20% decline in eGFR at 3 months postoperatively
ctDNA methylation-based MRD dynamics across 4 time points
ctDNA methylation-based MRD dynamics across 4 time points
Tumor RNA expression and DNA methylation profiling
Tumor RNA expression and DNA methylation profiling
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