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)