RecruitingRare disease

Study on Doxorubicin, Fluorouracil, and Oxaliplatin for Children and Adolescents with Primary Malignant Liver Cancer

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What is this trial about?

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

This clinical trial focuses on children and adolescents with primary malignant liver cancer, specifically Hepatoblastoma and Hepatocarcinoma. The study aims to explore the possibility of tailoring treatment based on the stage of the disease, reducing side effects without affecting the cure rate, improving treatment effectiveness, and selecting the best surgical methods. The trial involves several medications, including Doxorubicin Hydrochloride, Fluorouracil, Oxaliplatin, Cisplatin, Sorafenib Tosilate, Irinotecan Hydrochloride, Etoposide, Gemcitabine Hydrochloride, Vinorelbine, Carboplatin, and Sodium Thiosulfate (known as Pedmark). These medications are used to treat cancer and are administered either intravenously or orally, depending on the specific drug.

The purpose of the study is to improve the treatment of liver cancer in young patients by classifying them into different groups based on the disease stage and testing various treatment methods. Participants will receive one or more of the mentioned medications, and some may receive a placebo. The study will monitor the effectiveness of these treatments over a period, aiming to enhance survival rates and reduce treatment-related side effects. The trial will also assess the surgical options available for treating these liver cancers.

Throughout the study, participants will be closely monitored to evaluate their response to the treatment and any side effects they may experience. The trial seeks to find the most effective treatment combinations and surgical approaches to improve outcomes for children and adolescents with these types of liver cancer. The study is expected to continue until 2027, with the goal of advancing the understanding and treatment of Hepatoblastoma and Hepatocarcinoma in young patients.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm the presence of hepatoblastoma or hepatocarcinoma. This involves a series of tests and evaluations to determine the stage of the liver cancer.
Step 2
Treatment group assignment
Based on the initial assessment, the patient is classified into a specific treatment group according to the stage of the disease. This classification helps in individualizing the treatment plan.
Step 3
Chemotherapy administration
The patient receives chemotherapy drugs, which may include doxorubicin hydrochloride, fluorouracil, oxaliplatin, cisplatin, sorafenib tosilate, irinotecan hydrochloride, etoposide, sodium thiosulfate, gemcitabine hydrochloride, vinorelbine, and carboplatin. These drugs are administered intravenously, except for sorafenib, which is taken orally.
The dosage, frequency, and duration of administration depend on the specific treatment group and the patient's response to the therapy.
Step 4
Monitoring and evaluation
Throughout the treatment, regular monitoring is conducted to evaluate the patient's response to the chemotherapy. This includes assessing the reduction in tumor size and checking for any side effects.
The primary focus is on event-free survival, overall survival, adherence to surgical guidelines, chemotherapy-related toxicity, hearing loss, response, failure-free survival, and surgical resectability.
Step 5
Surgical intervention
If deemed necessary and feasible, surgical intervention is considered to remove the tumor. The decision for surgery is based on the effectiveness of the chemotherapy and the resectability of the tumor.
Step 6
Follow-up care
After completing the treatment, follow-up care is essential to monitor the patient's recovery and to check for any recurrence of the cancer. This involves regular check-ups and possibly additional treatments if required.

Who can join the trial?

5 criteria

The patient must have clinical signs of **Hepatoblastoma** or **Hepatocarcinoma**, which are types of **malignant tumors of the liver**.
The patient must have a **liver tumor**.
The patient must be **under 30 years old**.
The patient must sign an **informed consent** to participate in the study. This means they agree to join the study after being told about it.
Both **female** and **male** patients can participate.

Who cannot join the trial?

10 criteria

Patients who have a different type of cancer than the ones being studied, which are **hepatoblastoma** and **liver cancer** (also known as **hepatocarcinoma**).
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or instructions.
Patients who have other medical conditions that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have allergies or reactions to the study medication or similar drugs.
Patients who have a history of substance abuse or addiction.
Patients who have a serious infection or illness that could affect the study results.
Patients who have had a recent surgery or are planning to have surgery during the study period.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Górnośląskie Centrum Zdrowia Dziecka
Katowice, Poland
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Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw, Poland
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Kliniczny Szpital Wojewodzki Nr 2 Im. Sw. Jadwigi Krolowej W Rzeszowie
Rzeszow, Poland

Trial locations

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Investigated drugs

Cisplatin
is a chemotherapy medication used to treat various types of cancer, including liver cancer in children. It works by stopping the growth of cancer cells.
Doxorubicin
is another chemotherapy drug that is used to treat liver cancer. It helps to kill cancer cells and reduce the size of tumors.
Carboplatin
is similar to cisplatin and is used in chemotherapy to treat liver cancer. It works by interfering with the DNA of cancer cells, preventing them from multiplying.
Vincristine
is a chemotherapy medication that is used to treat liver cancer by stopping the growth of cancer cells.
5-Fluorouracil (5-FU)
is a chemotherapy drug that is used to treat liver cancer. It works by interfering with the DNA and RNA of cancer cells, which stops them from growing and dividing.
Gemcitabine
is a chemotherapy medication used to treat liver cancer. It works by slowing or stopping the growth of cancer cells.

What is already known about the treatment

Sorafenib – Sorafenib is administered orally in tablet form and is currently used in the treatment of certain types of liver cancer, including hepatoblastoma and hepatocarcinoma. It is well-documented in medical literature as a targeted therapy for these conditions. The main therapeutic indication for Sorafenib is to inhibit tumor growth in liver cancer. At the molecular level, it works by blocking specific proteins that promote cancer cell proliferation and angiogenesis, which is the formation of new blood vessels that supply the tumor. Sorafenib is classified pharmacologically as a kinase inhibitor.

Investigated diseases

Hepatoblastoma
This is a rare type of liver cancer that primarily affects children, usually under the age of three. It originates in the cells of the liver and can cause the liver to enlarge. As the disease progresses, it may spread to other parts of the body, such as the lungs. Symptoms can include a noticeable mass in the abdomen, weight loss, and jaundice. The exact cause of hepatoblastoma is not well understood, but it may be linked to certain genetic conditions. Early detection is crucial for managing the disease effectively.
Liver Cancer (Hepatocarcinoma)
Also known as hepatocellular carcinoma, this is the most common type of primary liver cancer in adults. It begins in the main type of liver cells called hepatocytes. The disease often develops in the context of chronic liver diseases, such as cirrhosis or hepatitis. As it progresses, it can lead to symptoms like abdominal pain, swelling, and jaundice. Liver cancer can spread to nearby organs or distant parts of the body. Risk factors include chronic alcohol consumption, hepatitis infections, and fatty liver disease.