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A Prospective, Single-Arm, Multicenter Clinical Study of High-Risk Localized and Locally Advanced Renal Clear Cell Carcinoma

NCT07741617 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-08-03

No results posted yet for this study

Summary

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.

Conditions

  • Urologic Neoplasms

Interventions

DRUG

Iparomlimab and Tuvonralimab in combination with Lenvatinib

Neoadjuvant phase (4 cycles, 21 days/cycle): From Cycle 1, Day 1: IV QL1706 (anti-PD-1/CTLA-4) 5 mg/kg Q3W for 4 cycles. Infusion interruptions allowed up to 8 hours total at room temperature. Concurrent oral lenvatinib 12 mg once daily for 4 cycles. Tumor response assessed every 2 cycles. After 4 cycles, subjects proceed to surgery unless early termination occurs due to clinical/radiographic progression (RECIST 1.1), unacceptable toxicity, consent withdrawal, or meeting discontinuation criteria. Adjuvant phase (13-17 cycles, 21 days/cycle): Based on postoperative pathology and investigator assessment, eligible patients (with consent) continue treatment. QL1706 5 mg/kg IV on Day 1 of each cycle, for 13-17 cycles. No lenvatinib in this phase. Key endpoints (implicit): safety and efficacy (ORR, pCR, DFS, OS) - but the summary focuses on treatment procedures as requested.

Sponsors & Collaborators

  • Wuxi No. 2 People's Hospital

    collaborator OTHER

  • Changzhou No.2 People's Hospital

    collaborator OTHER

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-15
Primary Completion
2028-08-15
Completion
2030-08-15

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07741617 on ClinicalTrials.gov