Iparomlimab and Tuvonralimab (QL1706) Combination With Lenvatinib as Neoadjuvant Therapy for ccRCC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSun Yat-sen University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
lymph node metastasis;
The tumor surrounds the renal artery;
Renal vein cancer thrombus;
Diffuse tumor growth, with no clear boundary from normal renal parenchyma;
Trial design
Design model
Single group
Treatments tested in this trial
QL1706 Combined With Lenvatinib
DrugLenvatinib 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.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Iparomlimab and Tuvonralimab (QL1706) combined with Lenvatinib as neoadjuvant therapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Decline rate of tumor R.E.N.A.L score
Time frame
Evaluation at the end of Cycle 2 or 4 (each cycle is 21 days) of QL1706 treatmentSecondary outcomes
1
ORR
Objective Response Rate (ORR) based on RECIST 1.1 criteria.
Time frame
Evaluation at the end of Cycle 2 or 4 (each cycle is 21 days) of QL1706 treatmentSponsors and contacts
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Source ClinicalTrials.gov