NCT07188311

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

A Single-arm, Open-label, Multicenter Phase II Clinical Study of Pucotenlimab Combined With Lenvatinib and Chemotherapy in the Treatment of Advanced, Relapsed/Refractory Hepatoblastoma in Children

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatoblastoma
• Pediatric Cancer

Interventions

Type	Name	Description
DRUG	Pucotenlimab ,Lenvatinib	A total of 24 cases are planned to be enrolled. All subjects will receive Pucotenlimab (3mg/kg, on Day 1, with a maximum dose not exceeding 200mg) once every 3 weeks (Q3W), in combination with Lenvatinib and Irinotecan. The chemotherapy regimen is fixed: Lenvatinib capsules 7mg/m2 (maximum 12mg) orally from Day 1 to 21 and Irinotecan 50mg/m2 from Day 1 to 5. Chemotherapy will be administered for 2 to 4 cycles, once every 3 weeks (Q3W).

Timeline

• Start date: 2025-04-10
• Primary completion: 2027-04-10
• Completion: 2027-12-10
• First posted: 2025-09-23
• Last updated: 2025-09-23

Locations

1 site across 1 country: China