Actively Recruiting
Pucotenlimab Combined With Lenvatinib and Chemotherapy for Advanced, Relapsed/Refractory Hepatoblastoma in Children in an Open-label Phase II Study
Led by Sun Yat-sen University · Updated on 2025-09-23
24
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research evaluates the combination of pucotenlimab, lenvatinib, and chemotherapy in children aged 2 to 18 years with advanced, relapsed, or refractory hepatoblastoma who have not responded to previous systemic treatments. It aims to assess this treatment approach in pediatric patients with measurable or non-measurable disease and includes those with stable brain metastases who have completed prior brain treatments. The study is an open-label, single-arm trial sponsored by Sun Yat-sen University. Participants receive pucotenlimab intravenously at a dose of 3 mg/kg (up to 200 mg) once every three weeks. Lenvatinib is taken orally once daily at 7 mg/m² (maximum 12 mg) for 21 days per cycle. Chemotherapy with irinotecan is administered intravenously at 50 mg/m² daily for five days per cycle. Each cycle lasts three weeks, and patients may undergo 2 to 4 cycles. Treatment continues until disease progression, unacceptable toxicity, or other specified reasons. Tumor tissue and blood samples are collected for biomarker testing. During the study, patients are closely monitored with tumor assessments and follow-up visits until disease progression or new anti-tumor therapy begins. Researchers evaluate progression-free survival as the primary outcome, tracking time until disease worsens or death. Secondary outcomes include overall survival over up to 24 months. Safety, laboratory tests, and performance status scores are monitored to ensure patient well-being throughout the trial, which may last up to two years.
CONDITIONS
Brief 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 enroll and sign informed consent
- Aged 2 to 18 years, any gender
- Histologically or cytologically confirmed advanced or metastatic hepatoblastoma
- Have received at least one prior systemic therapy with disease progression, relapse, or refractory disease
- At least one measurable lesion or non-measurable disease with elevated alpha-fetoprotein
- Karnofsky or Lansky Performance Status score at least 50 within 3 days before treatment
- Expected survival time of 3 months or more
- For brain metastases, must be clinically stable and off steroids for at least 28 days
- Archival tumor tissue or biopsy specimen available for biomarker analysis
- Negative pregnancy test for females of childbearing potential within 7 days before treatment
- Use reliable contraception during treatment and for 60 days after last dose
- Normal major organ function meeting specified blood counts and biochemistry criteria
You will not qualify if you...
- Received chemotherapy within 21 days before first study dose
- Received other anti-cancer treatment within 28 days or not recovered from prior treatment toxicity
- Proteinuria greater than 1 g/24 hours
- Gastrointestinal conditions affecting lenvatinib absorption
- Symptomatic central nervous system metastases or carcinomatous meningitis
- Other active malignant tumors within past 24 months except recurrent hepatoblastoma
- History of immunodeficiency or prior organ/stem cell transplant
- Previous treatment with immune checkpoint inhibitors, lenvatinib, or irinotecan
- History of pneumonia requiring steroids or current pneumonia
- Allergies to pucotenlimab or related drugs
- Recent gastrointestinal bleeding or risk thereof
- Significant cardiac diseases or uncontrolled hypertension
- Active infections including HIV, tuberculosis, or others above grade 2
- Unhealed surgery or severe postoperative complications
- Recent live-attenuated vaccination within 4 weeks
- Pregnant or lactating women
- History of substance abuse within 6 months
- Any other conditions deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 to 12 weeks
Participants receive pucotenlimab combined with lenvatinib and irinotecan chemotherapy. Pucotenlimab is given once every 3 weeks. Lenvatinib is taken orally daily for 21 days per cycle. Irinotecan chemotherapy is administered for 5 days per cycle. Chemotherapy lasts for 2 to 4 cycles, repeated every 3 weeks.
Visits every 3 weeks for treatment dosing and assessments
Trial Site Locations
Total: 1 location
1
Yizhuo Zhang
Guangdong, Guangzhou, China, 510060
Actively Recruiting
Research Team
Y
Yizhuo Zhang
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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