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 range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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;
. Have serious cardiovascular and cerebrovascular diseases, uncontrollable hypertension and diabetes;
. Patients who have long-term use of immunosuppressants after organ transplantation;
. Patients who are currently using immunosuppressive drugs;