Iparomlimab and Tuvonralimab (QL1706) Combination With Lenvatinib as Neoadjuvant Therapy for ccRCC (NCT07389629) | Clinical Trial Compass
RecruitingPhase 2
Iparomlimab and Tuvonralimab (QL1706) Combination With Lenvatinib as Neoadjuvant Therapy for ccRCC
China25 participantsStarted 2025-11-21
Plain-language 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).
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Voluntarily sign a written informed consent form (ICF).
✓. Age at the time of enrollment is \>= 18 and under 80 years old, with no gender restrictions.
✓. The physical fitness score of the Eastern Cooperative Oncology Group (ECOG) in the United States is 0 or 1;
✓. Expected survival period \>= 3 months.
✓. Preoperative biopsy pathology confirmed renal clear cell carcinoma or renal cell carcinoma mainly composed of clear cell carcinoma;
✓. ECOG score 0 or 1;
✓. The patient is willing to undergo kidney preservation surgery;
✓. 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);
Exclusion criteria
✕. lymph node metastasis;
✕. The tumor surrounds the renal artery;
✕. Renal vein cancer thrombus;
✕. Diffuse tumor growth, with no clear boundary from normal renal parenchyma;
✕. General poor condition, anesthesia assessment cannot tolerate general anesthesia surgery;
What they're measuring
1
Decline rate of tumor R.E.N.A.L score
Timeframe: Evaluation at the end of Cycle 2 or 4 (each cycle is 21 days) of QL1706 treatment