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

NCT07188311 | Recruiting

• 1 other identifier: SL-B2025-101-02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• PFS

  progression of the disease or the death

  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）.

Secondary Outcomes (1)

• OS

  The assessment of OS will be carried out over an estimated period of up to 24 months.

Study Arms (1)

Pucotenlimab plus a fixed regimen（Lenvatinib and Irinotecan)

EXPERIMENTAL

Drug: Pucotenlimab ,Lenvatinib

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).

Pucotenlimab plus a fixed regimen（Lenvatinib and Irinotecan)

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• Participants with proteinuria greater than 1+ in urinalysis will undergo 24-hour urine collection for quantitative assessment of proteinuria. Screeners with urine protein ≥1 g/24 hours will be ineligible for the study.
• Gastrointestinal malabsorption, gastrointestinal anastomosis, or any other conditions that may affect the absorption of lenvatinib.
• Clinically symptomatic central nervous system metastases and/or carcinomatous meningitis, or a history of leptomeningeal carcinomatosis; Any other active malignant tumors within the past 24 months, except for recurrent hepatoblastoma that is the reason for participation in this study; A history of congenital or acquired immunodeficiency; Previous allogeneic stem cell or solid organ transplantation; Previous receipt of immune checkpoint inhibitors (including but not limited to pembrolizumab, nivolumab), lenvatinib, or irinotecan; A history of (non-infectious) pneumonia requiring steroid treatment or current pneumonia.
• Patients with known or suspected allergic history to putilizumab or similar drugs, a history of hypersensitivity to chimeric or humanized antibodies or fusion proteins, or allergies to excipients of the study drug; A history of gastrointestinal bleeding within 4 weeks before enrollment, or a clear tendency for gastrointestinal bleeding (e.g., known active local ulcer lesions, fecal occult blood ≥++, and if persistent fecal occult blood +, gastroscopy should be performed), or other conditions judged by the investigator that may cause gastrointestinal bleeding (e.g., severe gastric fundus/esophageal varices); Cardiac diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina pectoris, or coronary artery bypass grafting within the past 6 months; congestive heart failure (New York Heart Association \[NYHA\] class \>2); arrhythmias that are poorly controlled or require pacemaker treatment; hypertension uncontrolled by drugs (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg);
• Active infections, including:
• Positive for human immunodeficiency virus (HIV) (HIV1/2 antibodies);
• Active tuberculosis;
• Other uncontrolled active infections (CTCAE V5.0 \>Grade 2); Failure to recover from surgery, such as unhealed incisions or severe postoperative complications; Vaccination with any live-attenuated vaccine within 4 weeks before enrollment or likely to be administered during the study period; seasonal influenza vaccines without live viruses are allowed.
• Pregnant or lactating women; A history of alcohol, psychotropic drug, or other substance abuse within the past 6 months; Any other conditions that the investigator deems make the patient ineligible for enrollment.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Yizhuo Zhang

Guangdong, Guangzhou, 510060, China

RECRUITING

MeSH Terms

Conditions

Hepatoblastoma; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type

Central Study Contacts

Yizhuo Zhang

CONTACT

020-87342460; zhangyzh@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Department of pediatric oncology

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 23, 2025
• Study Start: April 10, 2025
• Primary Completion (Estimated): April 10, 2027
• Study Completion (Estimated): December 10, 2027
• Last Updated: September 23, 2025

Record last verified: 2025-09

Locations

CN (1)