Study Design Prospective, single-arm, multicenter clinical study.
Study Drugs
Neoadjuvant phase: QL1706 (Aipaluo Tuoworilimab, an anti-PD-1/CTLA-4 combination antibody) plus lenvatinib.
Adjuvant phase: QL1706 monotherapy.
Target Population Patients with high-risk localized or locally advanced clear cell renal cell carcinoma (ccRCC) meeting AJCC staging criteria (e.g., cT3a G3-4 cN0M0, etc.) who are candidates for neoadjuvant therapy and surgical resection.
Treatment Flow
Screening (28 days): Informed consent obtained, baseline assessments completed.
Neoadjuvant phase (4 cycles, 21 days/cycle):
QL1706 5 mg/kg IV, Q3W; plus oral lenvatinib 12 mg QD.
Efficacy evaluation every 2 cycles; surgery after 4 cycles (unless early termination).
Adjuvant phase (13-17 cycles, 21 days/cycle):
Eligible patients continue QL1706 5 mg/kg IV, Q3W.
Imaging every 3 months until recurrence, new therapy, death, or completion of 21 cycles total.
Follow-up: Safety follow-up (90 days after last QL1706 dose or 30 days after last other drug, whichever is longer), then survival follow-up every 90 days.
Endpoints
Primary: Objective response rate (ORR) per RECIST 1.1.
Secondary: Pathological complete response rate (pCR), median disease-free survival (mDFS), 12-/24-month DFS rates, median overall survival (mOS), and safety.
Sample Size Planned enrollment: 54 subjects.