Clinical Trial

Pucotenlimab Combined With Lenvatinib and Chemotherapy in the Treatment of Advanced, Relapsed/Refractory Hepatoblastoma in Children

Recruiting
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Summary
This study is a single-cohort study. Pediatric patients with advanced, relapsed/refractory hepatoblastoma who have previously failed first-line or higher systemic therapy will receive 2 cycles of treatment with sintilimab combined with lenvatinib and chemotherapy (irinotecan). Patients may discontinue treatment due to disease progression, death, intolerable toxicity, withdrawal of informed consent, initiation of new anti-tumor therapy, or other reasons specified in the protocol, whichever occurs first. * Dose setting: * Sintilimab: The recommended dose is 3 mg/kg (maximum dose not exceeding 200 mg per administration), administered by intravenous infusion (60±15 minutes) once daily on Day 1. * Lenvatinib: 7 mg/m² (maximum 12 mg), taken orally once daily on Days 1-21. * Chemotherapy (irinotecan hydrochloride injection): * Irinotecan hydrochloride injection: 50 mg/m², administered by intravenous infusion once daily on Days 1-5. * Each 3 weeks constitutes one cycle. For patients who discontinue the study drug without radiological progression, follow-up and tumor assessment will continue until progressive disease (PD) occurs, new anti-tumor therapy is initiated, or death. * Tumor tissues and peripheral blood of patients will be collected for relevant tests.
Trial Details
NCT Number NCT07188311
Lead Sponsor Sun Yat-sen University
Conditions Hepatoblastoma, Pediatric Cancer
Enrollment 24 participants
Start Date 2025-04-10
Primary Completion 2027-04-10 (estimated)
Study Completion 2027-12-10 (estimated)
Updated on ClinicalTrials.gov 2025-09-23