Clinical trial · Interventional
Neoadjuvant PD-L1 Inhibitor Plus Anlotinib for Kidney Preservation in Complex Renal Cell Carcinoma
Neoadjuvant PD-L1 Blockade Combined With Anlotinib to Enable Nephron-Sparing Surgery in Patients With High-Complexity Locally Advanced Clear Cell Renal Cell Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Clear Cell Renal Cell Carcinoma | Clear Cell Renal Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TQB2450 + Anlotinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant TQB2450 + Anlotinib
- description
- 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
- interventionNames
- Drug: TQB2450 + Anlotinib
Primary outcomes (1)
- measure
- Rate of Successful Nephron-Sparing Surgery
- timeFrame
- At the time of surgery
- description
- Defined as the proportion of patients who undergo partial nephrectomy
Secondary outcomes (5)
- measure
- MDT-Defined Conversion to Nephron-Sparing Surgery
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * • 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 Exclusion Criteria: * • 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
References
Publications (0)
Data not yet available