#1 Clinical Trials Search in Europe

Sorafenib Tosilate

This article explores the use of Sorafenib Tosilate in clinical trials for children and adolescents with primary malignant liver cancer, specifically hepatoblastoma and hepatocarcinoma. The drug is being studied as part of a comprehensive treatment approach aimed at improving outcomes and reducing side effects in young patients with these challenging conditions.

Table of Contents

What is Sorafenib Tosilate?

Sorafenib Tosilate, also known as Sorafenib tosylate or simply Sorafenib, is a medication used in the treatment of certain types of cancer[1]. It belongs to a class of drugs called protein kinase inhibitors, which work by interfering with the growth and spread of cancer cells in the body[1].

How Does Sorafenib Work?

Sorafenib works by blocking specific proteins in cancer cells that are responsible for cell growth and division. By doing this, it helps to slow down or stop the growth of cancer cells[1]. This medication is part of a targeted therapy approach, which means it is designed to attack cancer cells while causing less harm to normal cells compared to traditional chemotherapy.

Medical Conditions Treated

Sorafenib is primarily used in the treatment of liver cancer. Specifically, it is used for:

  • Hepatoblastoma: A rare type of liver cancer that typically affects young children[1].
  • Hepatocellular carcinoma (HCC): The most common type of primary liver cancer in adults, also referred to as hepatocarcinoma[1].

These conditions are part of a group of diseases known as primary malignant liver cancers, which means the cancer originates in the liver rather than spreading from another part of the body.

How is Sorafenib Administered?

Sorafenib is taken orally, which means it is administered by mouth[1]. This makes it convenient for patients as it can be taken at home, unlike some cancer treatments that require hospital visits for intravenous administration.

Dosage Information

The dosage of Sorafenib can vary depending on the individual patient and their specific condition. However, based on the clinical trial information provided:

  • The maximum daily dose is typically 400 mg[1].
  • The maximum total dose over the course of treatment may be up to 40,000 mg[1].
  • The treatment period can last up to 100 days[1].

It’s important to note that these are maximum amounts, and your doctor will prescribe the appropriate dose for your specific situation. Never adjust your dose without consulting your healthcare provider.

Sorafenib in Clinical Trials

Sorafenib is being studied in clinical trials for the treatment of liver cancer in children and adolescents. The trial mentioned in the source material is a Phase 3 trial, which is an advanced stage of clinical research[1]. This trial aims to:

  1. Individualize treatment for malignant liver tumors in children based on disease stage.
  2. Reduce treatment side effects without significantly affecting cure rates.
  3. Improve curability in cases where current therapy is not effective enough.
  4. Identify the most effective surgical treatment methods.

The trial also has secondary objectives, including identifying biological features and genetic factors of liver cancer, and modifying the classification of liver tumors in children[1].

Potential Side Effects

While the specific side effects of Sorafenib are not detailed in the provided information, it’s important to be aware that all medications can have side effects. Common side effects of cancer treatments may include fatigue, nausea, and changes in appetite. The clinical trial mentioned aims to reduce the occurrence of treatment side effects, which suggests that managing and minimizing side effects is a priority in the use of this medication[1].

Always discuss potential side effects with your healthcare provider, and report any unusual symptoms you experience while taking Sorafenib.

Aspect Details
Drug Name Sorafenib Tosilate
Drug Category Protein kinase inhibitor
Administration Route Oral
Maximum Daily Dose 400 mg
Maximum Total Dose 40,000 mg
Treatment Duration Up to 100 days
Target Conditions Hepatoblastoma and Hepatocarcinoma (liver cancer)
Age Group Children and adolescents under 30 years old
Trial Phase Phase 3; therapeutic confirmatory
Main Objectives Individualize treatment, reduce side effects, improve curability, optimize surgical methods

FAQ

  • What is Sorafenib Tosilate and how does it work? Sorafenib Tosilate is a protein kinase inhibitor, which means it helps block certain proteins that cancer cells need to grow and spread. In this trial, it's being studied as a potential treatment for children and adolescents with liver cancer.
  • Who is eligible for this clinical trial? The trial is open to individuals under 30 years old who show clinical signs of hepatoblastoma or hepatocarcinoma (malignant tumors of the liver) and have a liver tumor. Participants must sign an informed consent to join the study.
  • What are the main objectives of this clinical trial? The trial aims to individualize treatment based on disease stage, reduce side effects without compromising cure rates, improve curability where current therapies are less effective, and select the most effective surgical treatment methods.
  • How is Sorafenib Tosilate administered in this trial? Sorafenib Tosilate is given orally, with a maximum daily dose of 400 mg. The maximum total dose amount is 40,000 mg over a treatment period of up to 100 days.
  • What are some reasons why a patient might not be eligible for this trial? Patients who have previously received chemotherapy, have a recurrence of the disease, have had an organ transplant, have an uncontrolled generalized infection, are pregnant or breastfeeding, or have other associated cancers are not eligible for this trial.

Ongoing Clinical Trials on Sorafenib Tosilate

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

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Poland

Glossary

  • Hepatoblastoma: A rare type of liver cancer that typically occurs in young children, usually under the age of 3.
  • Hepatocarcinoma: Also known as hepatocellular carcinoma, this is the most common type of primary liver cancer that usually occurs in adults but can also affect children and adolescents.
  • Sorafenib Tosilate: A type of drug known as a protein kinase inhibitor, used to treat certain types of cancer by blocking proteins that help cancer cells grow and spread.
  • Event-free survival: The length of time after treatment during which no specified adverse events (such as disease progression or recurrence) are detected.
  • Overall survival: The length of time from the start of treatment that patients are still alive.
  • Chemotherapy-related toxicity: Side effects or complications that occur as a result of chemotherapy treatment.
  • Surgical resectability: The ability to surgically remove a tumor completely.
  • Protein kinase inhibitor: A type of drug that blocks specific enzymes called protein kinases, which are involved in many cell functions, including cell signaling, growth, and division.

References

  1. http://clinicaltrials.eu/trial/study-on-doxorubicin-fluorouracil-and-oxaliplatin-for-children-and-adolescents-with-primary-malignant-liver-cancer/