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Recruiting Phase 2 NCT07389629

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

Trial Parameters

Condition Iparomlimab and Tuvonralimab
Sponsor Sun Yat-sen University
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 25
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2025-11-21
Completion 2027-12-31
Interventions
QL1706 Combined With Lenvatinib

Brief 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 Criteria

Inclusion Criteria: 1. Voluntarily sign a written informed consent form (ICF). 2. Age at the time of enrollment is \>= 18 and under 80 years old, with no gender restrictions. 3. The physical fitness score of the Eastern Cooperative Oncology Group (ECOG) in the United States is 0 or 1; 4. Expected survival period \>= 3 months. 5. Preoperative biopsy pathology confirmed renal clear cell carcinoma or renal cell carcinoma mainly composed of clear cell carcinoma; 6. ECOG score 0 or 1; 7. The patient is willing to undergo kidney preservation surgery; 8. Indications for kidney preservation surgery are available, but limited renal cancer with high difficulty of kidney preservation surgery (stage T1N0M0 or T2N0M0, must meet R.E.N.A.L. score \>= 10); 9. At least one measurable lesion (according to mRECIST v1.1 standard) that is suitable for repeated and accurate measurements. 10. Good organ function, screening laboratory test results meet the following criteria: (1) Hematology (no blood componen

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