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Study of drug combinations including cisplatin, carboplatin, doxorubicin, fluorouracil, vincristine, etoposide, irinotecan, gemcitabine, oxaliplatin and sorafenib for children with hepatoblastoma or hepatocellular carcinoma

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial 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

  2. Step 2

    Treatment 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

  3. Step 3

    Treatment 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

  4. Step 4

    Response 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

  5. Step 5

    Follow-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 trial?

8 criteria

  • 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 trial?

12 criteria

  • 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
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Investigated drugs

  • Cisplatin

    is a chemotherapy medication used to treat various types of cancer. It works by interfering with cancer cell DNA, preventing tumor growth.

  • Fluorouracil

    (also known as 5-FU) is a chemotherapy drug that blocks certain cell processes needed for cancer cell growth and multiplication.

  • Vincristine

    is a chemotherapy medication derived from a plant that stops cancer cells from dividing and growing.

  • Doxorubicin

    is a chemotherapy drug that works by slowing or stopping cancer cell growth. It belongs to a class of drugs called anthracyclines.

  • Carboplatin

    is a platinum-based chemotherapy drug that damages the genetic material inside cancer cells, preventing them from multiplying.

  • Etoposide

    is a chemotherapy medication that interferes with cancer cell DNA, leading to cell death.

What is already known about the treatment

  • Cisplatin

    An intravenously administered platinum-based chemotherapy drug that works by binding to DNA and interfering with cell division. It belongs to the alkylating agents class and is primarily used in the treatment of hepatoblastoma and hepatocellular carcinoma, particularly in pediatric patients. The medication acts by creating cross-links in DNA that trigger apoptosis in cancer cells.

  • Carboplatin

    A platinum-based chemotherapy medication given through intravenous infusion that causes less severe side effects than cisplatin while maintaining similar anti-cancer properties. It belongs to the platinum-containing compounds class and works by interfering with DNA replication in cancer cells, making it effective in treating liver cancers in children.

  • Doxorubicin

    An intravenous chemotherapy medication from the anthracycline class that works by blocking DNA and RNA synthesis in cancer cells. It is commonly used in combination therapy for hepatoblastoma and hepatocellular carcinoma, interfering with the growth and spread of cancer cells through multiple mechanisms.

  • Vincristine

    A plant-derived chemotherapy medication administered intravenously that belongs to the vinca alkaloid class. It works by preventing cancer cells from dividing by disrupting microtubules during cell division, and is often used as part of combination therapy protocols for liver cancers.

  • Sorafenib

    An oral targeted therapy medication that belongs to the kinase inhibitor class. It works by blocking specific proteins that promote cancer cell growth and blood vessel formation, used specifically in advanced hepatocellular carcinoma to slow tumor growth and spread.

  • Irinotecan

    An intravenously administered chemotherapy drug that belongs to the topoisomerase inhibitor class. It works by preventing DNA repair in cancer cells, leading to cell death, and is used as part of combination therapy protocols in resistant or advanced liver cancers.

Investigated diseases

  • 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.

Trial detailsLast updated 4 Nov 2026
Age18+ yearsPhasePhase IIITrial ID2024-516110-38-00Protocol codeRG_15-114Estimated enrolment449 patientsSponsorThe University Of Birmingham

sourced from the EU Clinical Trials Register and site verification

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