Actively Recruiting
A Prospective Multicenter Clinical Study of the South China Collaborative Group Protocol for the Treatment of Hepatoblastoma in Children and Adolescents
Led by Sun Yat-sen University · Updated on 2025-12-23
100
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Hepatoblastoma is the most common malignant liver tumor in infants and young children, making up 65% of pediatric liver cancers under 15 years old. While early-stage patients have a survival rate above 90%, those with high-risk disease face survival rates around 40%, indicating a need for better treatments. Different definitions of high-risk hepatoblastoma exist internationally, and intensified chemotherapy regimens have shown improved survival but also increased side effects. This trial aims to find the best chemotherapy approaches for children with hepatoblastoma in China and to explore a new blood test for monitoring the disease. Participants will be grouped by risk level and receive tailored treatments. Very low-risk patients may have surgery alone or single-agent chemotherapy with cisplatin (DDP). Low-risk patients get 2 to 4 cycles of DDP chemotherapy before surgery and 2 cycles after. Intermediate-risk patients are randomized to either SIOPEL-3 HR chemotherapy or C5VD chemotherapy for 2 to 4 cycles, followed by surgery and additional chemotherapy to total 6 cycles. High-risk patients receive a combination chemotherapy regimen including C-CD, ICE, and sorafenib for 3 to 5 cycles, followed by surgery and total 6 to 7 chemotherapy cycles. Blood samples will be collected regularly to monitor a biomarker called 5hmc. During the study, participants will undergo staging, treatment cycles, elective surgery, and follow-up assessments. Researchers will monitor progression-free survival and overall survival over 24 months. The study includes collection of peripheral blood for epigenetic profiling to evaluate treatment response and detect recurrence. Safety and consistency of treatment outcomes will also be assessed. The total duration and detailed monitoring will help optimize therapies and improve future care for children with hepatoblastoma.
CONDITIONS
Brief Title
A Prospective Multicenter Clinical Study of SCCG Protocol and ctDNA 5hmc in Predicting the Chemotherapy Sensitivity and Monitoring the Recurrence and Metastasis of Hepatoblastoma in Children and Adolescents
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with primary hepatoblastoma confirmed by pathology
- Age less than 18 years old
- Informed consent obtained from guardians with signed consent form
You will not qualify if you...
- Recurrent hepatoblastoma or other malignant tumor
- Age over 18 years old
- Patients with other tumors who have received chemotherapy or abdominal radiotherapy
- Patients with heart, brain, or kidney failure
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 - Varies by risk group; typically 3 to 7 courses of chemotherapy with elective surgery in most groups
Participants receive chemotherapy and/or surgery according to their risk group classification to treat hepatoblastoma.
Multiple visits for chemotherapy and surgery as per treatment plan
Duration - Up to 24 months
Participants have peripheral blood drawn regularly for 5hmc dynamic monitoring to evaluate treatment efficacy and detect recurrence.
Regular blood draws for monitoring during and after treatment
Trial Site Locations
Total: 2 locations
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
2
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
Y
Yizhuo Zhang, PhD
J
Junting Huang, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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