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

NCT07188311 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-09-23

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-10
Primary Completion
2027-04-10
Completion
2027-12-10

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07188311 on ClinicalTrials.gov