Actively Recruiting
Pucotenlimab Combined With Lenvatinib and Chemotherapy in the Treatment of Advanced, Relapsed/Refractory Hepatoblastoma in Children
Led by Sun Yat-sen University · Updated on 2025-09-23
24
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Pucotenlimab Combined With Lenvatinib and Chemotherapy in the Treatment of Advanced, Relapsed/Refractory Hepatoblastoma in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Aged 2 to 18 years, any gender
- Histologically or cytologically confirmed locally advanced or metastatic hepatoblastoma
- Received at least one line of systemic therapy with disease progression, relapse, or refractory disease
- At least one measurable lesion by imaging or non-measurable disease with elevated alpha-fetoprotein
- Karnofsky score (≥16 years) or Lansky score (<16 years) of at least 50 within 3 days before treatment
- Expected survival of 3 months or more
- If brain metastases are present, completed brain treatment, stable, asymptomatic, and off steroids for at least 28 days
- Available tumor tissue for biomarker analysis or approved enrollment without biopsy
- Negative pregnancy test for females of childbearing potential within 7 days before treatment
- Use of reliable contraception during treatment and for 60 days after last dose
- Normal major organ function meeting specified blood count, liver, kidney, coagulation, and heart enzyme criteria
You will not qualify if you...
- Received chemotherapy within 21 days before first study drug dose
- Received other anti-cancer treatments within 28 days or not recovered from related toxicity
- Proteinuria >1 g/24 hours or >1+ on urine test without confirmation
- Gastrointestinal conditions affecting lenvatinib absorption
- Symptomatic central nervous system metastases or carcinomatous meningitis
- Other active cancers within past 24 months except recurrent hepatoblastoma
- History of immunodeficiency or prior stem cell/organ transplant
- Prior treatment with immune checkpoint inhibitors, lenvatinib, or irinotecan
- History or current pneumonia requiring steroids
- Known allergy to study drugs or components
- Recent gastrointestinal bleeding or high risk for bleeding
- Significant cardiac disease including recent myocardial infarction, severe angina, heart failure NYHA >2, uncontrolled arrhythmias, or uncontrolled hypertension
- Active infections including HIV, tuberculosis, or other uncontrolled infections
- Unhealed surgical wounds or severe postoperative complications
- Live-attenuated vaccine within 4 weeks before enrollment
- Pregnant or breastfeeding
- Recent history of substance abuse
- Any other condition deemed unsafe or unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Yizhuo Zhang
Guangdong, Guangzhou, China, 510060
Actively Recruiting
Research Team
Y
Yizhuo Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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