A Multicenter Study to Improve Chemotherapy and Use Blood Tests to Monitor Hepatoblastoma in Children and Teens

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.

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