NCT07602101Not yet recruitingPhase 2
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 · Last updated 22 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 33 (estimated)
- First submitted
- 7 May 2026
- Start date
- 31 May 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- RenJi Hospital
- Diseases
- Kidney cancer
- NCT number
- NCT07602101
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 33
- From 31 May 2026 to the primary completion date, 31 Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- • 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
Who the study is looking for
- • 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.