Neoadjuvant PD-L1 Inhibitor Plus Anlotinib for Kidney Preservation in Complex Renal Cell Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TQB2450 + Anlotinib.
- Who it may be relevant to
- Registry conditions: Clear Cell Renal Cell Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Neoadjuvant PD-L1 Blockade Combined With Anlotinib to Enable Nephron-Sparing Surgery in Patients With High-Complexity Locally Advanced Clear Cell Renal Cell Carcinoma
Overview
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.
Detailed description
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.
Interventions
- 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
Primary outcome measures
- Rate of Successful Nephron-Sparing Surgery [Time frame: At the time of surgery]
Secondary outcome measures (5)
- MDT-Defined Conversion to Nephron-Sparing Surgery [Time frame: Pre-surgery]
- Objective Response Rate (ORR) [Time frame: Pre-surgery]
- Pathologic Complete Response (pCR) [Time frame: 1 month after surgery]
- Renal Function Preservation [Time frame: 3 month after surgery]
- Safety and Tolerability [Time frame: enrollment to 90 days after surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07602101 · SPARE-KIDNEY