RecruitingPhase 2NCT07389629

Iparomlimab and Tuvonralimab (QL1706) Combination With Lenvatinib as Neoadjuvant Therapy for ccRCC

The Efficacy and Safety of Iparomlimab and Tuvonralimab (QL1706) Combined With Lenvatinib as Neoadjuvant Therapy in Renal Cancer With Partial Nephrectomy Indications But High Surgical Risk：A Single Arm, Phase II Clinical Study

Sponsor

Sun Yat-sen University

Enrollment

25 participants

Start Date

Nov 21, 2025

Study Type

INTERVENTIONAL

Conditions

Neoadjuvant Therapy Clear Cell Renal Cell Carcinoma Iparomlimab and Tuvonralimab

Summary

Through the combination of aparolitovorelli monoclonal antibody and lenvatinib neoadjuvant therapy, partial nephrectomy can be successfully and safely performed in patients with localized renal cell carcinoma (T1N0M0 or T2N0M0) who have indications for kidney preservation surgery but have difficulty in preserving the kidney (R.E.N.A.L. score \>= 10).

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether a combination of two immunotherapy drugs (iparomlimab and tuvonralimab, also called QL1706) plus a targeted drug called lenvatinib can shrink kidney tumors before surgery. The goal is to make kidney-sparing surgery easier and more successful in patients with clear cell kidney cancer. **You may be eligible if...** - You are 18 to 79 years old - You have been diagnosed with clear cell kidney cancer (confirmed by biopsy) - Your cancer is at stage T1 or T2 with no spread to lymph nodes or other organs, and your tumor is considered difficult to remove while saving the kidney (R.E.N.A.L. score ≥10) - You are willing to have kidney-sparing surgery - You are in reasonably good health (ECOG score 0 or 1) **You may NOT be eligible if...** - You have already received treatment for kidney cancer - Your cancer has spread beyond the kidney - You have certain heart, liver, or blood pressure conditions that are uncontrolled - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGQL1706 Combined With Lenvatinib

Lenvatinib Treatment Lenvatinib (8mg \[body weight \< 60 kg\] or 12 mg \[body weight ≥ 60 kg\]) orally once daily, with or without food. Intravenous Infusion of QL1706(Injection) Infuse QL1706 at a dose of 5mg/kg intravenously every three weeks, constituting one treatment cycle, a total of 2 or 4 cycles.

Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, China

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NCT07389629

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