hepatoblastoma, hepatocellular carcinoma hepatoblastoma, hepatocellular carcinoma
Conditions
Interventions
Group A - Very Low Risk HB Patients: The patients will have a primary resection of their tumor. Following surgical resection, patients with Well Differentiated Fetal(WDF) histology must receive no a
Sponsors
Hiyama Eiso
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Clinical diagnosis of hepatoblstoma (HB) and histologically defined diagnosis of HB or hepatocellular carcinoma (HCC).* 2)Age <=30 years 3)Written informed consent for trial entry
Exclusion criteria
Exclusion criteria: 1)Any previous chemotherapy or currently receiving anti-cancer agents 2)Recurrent disease 3)Previously received a solid organ transplant; other than orthotopic liver transplantation (OLT). 4)Uncontrolled infection 5)Unable to follow or comply with the protocol for any reason 6)Second malignancy 7)Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)To evaluate if the treatment of Low Risk hepatoblastoma (HB) can be reduced (Group B1) 2)To compare different treatment regimens for Intermediate risk HB (Group C) 3)To compare different post induction treatment regimens for High Risk HB (Group D2) 4)To determine if the outcome is improved when GEMOX is added to PLADO in the treatment of unresected hepatocellular carcinoma HCC (Group F) 5)To collect samples for biological and toxicity studies. (All groups) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)To report outcome (including event-free survival (EFS), failure-free survival (FFS), overall survival (OS), toxicity and surgical outcome) in all patient groups. 2)To validate a new global risk stratification, defined by Children's Hepatic Tumours International Collaboration (CHIC) 3)To evaluate clinically relevant factors, including the following: - Provide a comprehensive and highly-validated panel of diagnostic and prognostic biomarkers - Determine if paediatric HCC is a biologically different entity to adult HCC - Develop genomic and/or biomarker analysis to predict children who may have an increased risk of developing toxicity with chemotherapy. 4)To establish a collection of clinically and pathologically-annotated biological samples. 5)Evaluate a surgical planning tool for an impact on decision making processes in POST-TEXT III and IV HB | — |
Countries
East Asia(Taiwan, Hong Kong, Singapore and other), Japan
Contacts
Public ContactEiso Hiyama
Hiroshima University Hospital
Outcome results
None listed