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

Sponsor
Sun Yat-sen University
Study ID
NCT07188311
Status
Recruiting
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Conditions

  • Hepatoblastoma
  • Pediatric Cancer

Eligibility Criteria

Sex
ALL
Age
2 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Pucotenlimab ,Lenvatinib — DRUG
    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).

Study Details

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.

Key Dates

First listed
Sep 23, 2025
Start date
Apr 10, 2025
Status verified
Sep 2025
Primary completion
Apr 10, 2027
Completion
Dec 10, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pucotenlimab plus a fixed regimen（Lenvatinib and Irinotecan)

Primary Outcome Measure

PFS [ Time Frame: PFS is defined as the time interval from the start of treatment until the occurrence of disease progression or death of the patient from any cause, whichever happens first (up to 24 months）. ]

Central Contacts

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