A Phase 2 interventional study of TQB2450 + Anlotinib in Clear Cell Renal Cell Carcinoma, sponsored by RenJi Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by RenJi Hospital · Phase 2, Interventional, and Treatment
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.
Patients with anatomically high-complexity locally advanced ccRCC (RENAL score ≥10) often require radical nephrectomy or technically challenging partial nephrectomy, resulting in increased perioperative risks and long-term renal function impairment. Evidence supporting neoadjuvant strategies in this specific high-complexity population remains limited.
This study evaluates a novel neoadjuvant approach combining PD-L1 blockade (TQB2450) with the multi-target tyrosine kinase inhibitor anlotinib. PD-L1 inhibition restores anti-tumor immunity, while antiangiogenic therapy promotes vascular normalization and enhances immune cell infiltration. This dual mechanism may improve tumor shrinkage and facilitate surgical conversion, particularly in central or hilar tumors.
Patients will receive 2-4 cycles of neoadjuvant therapy, followed by imaging assessment and multidisciplinary team (MDT) evaluation. Surgery will be performed within a predefined window after treatment completion.
A key translational component includes longitudinal ctDNA methylation-based MRD monitoring at four time points (baseline, after 2 cycles, pre-surgery, and post-surgery), combined with tumor tissue RNA expression and DNA methylation profiling, as well as radiomics feature extraction. These data will be integrated using machine learning algorithms to construct predictive models for treatment response and nephron-sparing surgery feasibility.
1,965 studies on the registry are indexed under Carcinoma, Renal Cell; 378 are open to participants now.
This study's planned enrollment of 33 is below the median of 42 across 1,480 interventional studies indexed under Carcinoma, Renal Cell.
Browse Carcinoma, Renal Cell studies →RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Age ≥18 years
Exclusion Criteria:
Prior systemic therapy for RCC (including ICIs or TKIs)
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
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
Rate of Successful Nephron-Sparing Surgery
Defined as the proportion of patients who undergo partial nephrectomy
Time frame: At the time of surgery
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
Time frame: Pre-surgery
Objective Response Rate (ORR)
Assessed by RECIST v1.1
Time frame: Pre-surgery
Pathologic Complete Response (pCR)
Pathologic Complete Response (pCR) after surgery
Time frame: 1 month after surgery
Renal Function Preservation
Proportion of patients with ≤20% decline in eGFR at 3 months postoperatively
Time frame: 3 month after surgery
Safety and Tolerability
Incidence of Grade ≥3 treatment-related adverse events (CTCAE v5.0)
Time frame: enrollment to 90 days after surgery
ctDNA methylation-based MRD dynamics across 4 time points
ctDNA methylation-based MRD dynamics across 4 time points
Time frame: enrollment to 90 days after surgery
Tumor RNA expression and DNA methylation profiling
Tumor RNA expression and DNA methylation profiling
Time frame: enrollment to 90 days after surgery
No study locations are listed for this record.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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RenJi Hospital