Study of drug combinations including cisplatin, carboplatin, doxorubicin, fluorouracil, vincristine, etoposide, irinotecan, gemcitabine, oxaliplatin and sorafenib for children with hepatoblastoma or hepatocellular carcinoma
This clinical trial is studying treatments for Hepatoblastoma and Hepatocellular Carcinoma, which are types of liver cancer. The study will test several chemotherapy medications including cisplatin, carboplatin, doxorubicin, fluorouracil, vincristine, etoposide, irinotecan, gemcitabine, oxaliplatin, and sorafenib.
The purpose of this study is to evaluate different treatment combinations for various risk groups of liver cancer patients. The treatments will be given through infusion into a vein or as tablets, depending on the specific medication. The study will compare different combinations of these medications to find out which ones work best for specific patient groups while monitoring side effects.
Patients will be divided into different groups based on their specific type of liver cancer and risk level. The study will track how well the cancer responds to treatment, how long patients remain free of cancer progression, and overall survival. Throughout the treatment, doctors will closely monitor patients’ heart, kidney, and hearing function, as some of these medications can affect these areas.
1Initial medical assessment
A medical evaluation will confirm if you have hepatoblastoma (HB) or hepatocellular carcinoma (HCC)
Your doctor will perform tests to check your heart function, blood counts, and kidney function
Your medical team will determine which risk group (A through F) your condition falls into
2Treatment assignment
Based on your specific condition and risk group, you will be assigned to one of the following treatment paths:
Group A (Very Low-Risk): Monitoring only, no treatment required
Group B (Low-Risk): 4 or 6 cycles of chemotherapy
Group C (Intermediate Risk): Treatment with different combinations of chemotherapy drugs
Group D (High-Risk): Treatment based on how your disease responds to initial therapy
Group E (Resected HCC): Standard treatment after tumor removal
Group F (Unresected HCC): Combined chemotherapy treatment with multiple medications
3Treatment administration
Most medications will be given through intravenous (IV) infusion
Some treatments may be given as oral medication
Regular monitoring of your blood counts and organ function will continue throughout treatment
Treatment duration will vary depending on your assigned group and response to therapy
4Response monitoring
Your medical team will regularly assess how well the treatment is working
Imaging scans will be performed to check tumor response
Blood tests will monitor your AFP levels (a tumor marker)
Side effects will be monitored and recorded throughout treatment
5Follow-up care
Regular check-ups will continue after treatment completion
Hearing tests will be performed to monitor potential side effects
Long-term monitoring will continue until the end of the study period in 2027
Who Can Join the Study?
Age must be 30 years or younger
Must have either:
– A clinical diagnosis of hepatoblastoma (HB)
– A confirmed diagnosis of hepatoblastoma (HB)
– A confirmed diagnosis of hepatocellular carcinoma (HCC)
Must have good heart function shown by either:
– Heart shortening fraction of 28% or higher
– Heart ejection fraction of 47% or higher
Blood test results must show:
– White blood cell count above 0.75 x 109/L
– Platelet count above 75 x 109/L
– Normal blood clotting time
– Normal levels of potassium, magnesium, and calcium
Must have good kidney function shown by:
– Normal creatinine levels for age, or
– Kidney filtration rate of 60mL/min/1.73m2 or higher
Must provide written informed consent to participate in the trial
For women who can become pregnant:
– Must have a negative pregnancy test before starting
– Must agree to use effective birth control during the trial
Must be considered healthy enough by doctors to receive the specific treatment for their group
Who Cannot Join the Study?
Age less than 6 months or over 30 years at the time of diagnosis
Previous treatment with chemotherapy or other medications for liver cancer
Presence of other types of cancer besides hepatoblastoma or hepatocellular carcinoma (liver cancers)
Severe heart problems that would make chemotherapy unsafe
Severe kidney problems that would affect treatment
Pregnancy or breastfeeding
Active, uncontrolled infections
Known allergies to any of the study medications
Inability to follow study procedures or attend scheduled visits
Mental conditions that prevent understanding of the study requirements
Participation in other clinical trials within the last 30 days
Life-threatening conditions unrelated to liver cancer
Hepatoblastoma – A rare liver cancer that typically develops in children under the age of three. It begins in the cells of the liver and can form a mass or several masses within the liver tissue. The tumor usually starts in embryonic liver cells that normally develop into mature liver cells.
Hepatocellular Carcinoma – A primary liver cancer that begins in hepatocytes, which are the main type of liver cell. The disease typically develops gradually as damaged liver cells undergo changes that cause them to become cancerous. It can appear as a single tumor or multiple tumors throughout the liver.
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