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Study on the Effectiveness of 188Re-SSS Lipiodol Therapy for Patients with Non-Operable Liver Cancer

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What is this study about?

This clinical trial is focused on studying a type of liver cancer called hepatocellular carcinoma, which cannot be removed through surgery. The treatment being tested is called 188Re-SSS Lipiodol, a solution that is injected directly into the liver’s blood vessels. This treatment is a form of internal radiation therapy, which means it uses radiation to target and kill cancer cells from within the body.

The purpose of the study is to evaluate how effective this treatment is for patients with non-operable hepatocellular carcinoma. Participants in the study will receive the 188Re-SSS Lipiodol injection and will be monitored over time to see how their cancer responds to the treatment. The study will look at various outcomes, such as how well the cancer shrinks, how long it takes for the cancer to progress, and the overall survival of the patients. These outcomes will be assessed at different intervals, including one month, three months, and every three months up to two years after the treatment.

Throughout the study, researchers will also measure levels of a protein called alpha-fetoprotein (AFP) in the blood, which can indicate how the cancer is responding to the treatment. A decrease in AFP levels may suggest a positive response to the therapy. The study aims to provide valuable information on the potential benefits of 188Re-SSS Lipiodol for patients with this type of liver cancer.

1 joining the study

Upon joining the study, you will be required to provide your consent by signing an informed consent form. This confirms your understanding of the study and your willingness to participate.

You must meet certain criteria to participate, including being 18 years or older, having a specific type of liver cancer that cannot be operated on, and having a good general health status as determined by a performance scale.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes verifying your medical history and conducting necessary tests to ensure you meet all the study requirements.

Your liver condition will be evaluated, and the extent of tumor involvement will be assessed to ensure it is less than 50% of the liver.

3 treatment administration

You will receive the treatment called 188Re-SSS Lipiodol, which is a solution for injection. This will be administered directly into the artery that supplies blood to the liver, a method known as intraarterial use.

The treatment aims to deliver targeted radiation therapy to the liver tumor.

4 follow-up assessments

After the treatment, follow-up assessments will be conducted at 1 month, 3 months, and every 3 months up to 24 months. These assessments will evaluate the response of the tumor to the treatment.

The primary focus will be on measuring the tumor’s response, progression of the disease, and overall survival.

5 monitoring and evaluation

Throughout the study, your health and response to the treatment will be closely monitored. This includes regular blood tests to measure levels of a protein called alpha-fetoprotein (AFP), which can indicate how well the treatment is working.

The study will also track the time it takes for the cancer to progress and overall survival rates.

Who Can Join the Study?

  • Must be 18 years or older.
  • Have an ECOG Performance Status of 0-1, which means you are fully active or have some symptoms but can still carry out light work.
  • Have a diagnosis of Hepatocellular Carcinoma (a type of liver cancer) confirmed by tests or according to specific medical guidelines.
  • The cancer must be non-operable and cannot be treated with a procedure called ablation therapy.
  • Have at least one tumor that can be measured using a specific method called mRECIST.
  • The tumor must involve less than 50% of the liver.
  • Be classified as stage A to C according to the BCLC classification, which is a system used to stage liver cancer.
  • If you have cirrhosis (liver scarring), it must be compensated cirrhosis, classified as Child Pugh A or B7, meaning the liver is still functioning well.
  • Must provide informed consent by signing a document that explains the study, or have a legal representative sign it for you.

Who Cannot Join the Study?

  • Patients who have had surgery to remove the liver cancer cannot participate.
  • Patients who are younger than 18 years old or older than 65 years old are not eligible.
  • Patients who are pregnant or breastfeeding cannot take part in the study.
  • Patients with other serious health conditions that might interfere with the study treatment are excluded.
  • Patients who have participated in another clinical trial within the last 30 days are not allowed to join.
  • Patients who have allergies to the study medication or its ingredients cannot participate.
  • Patients with a history of alcohol or drug abuse may be excluded.
  • Patients who are unable to follow the study procedures or attend the required visits are not eligible.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
14.02.2024

Trial locations

Investigated drugs:

188Re-SSS lipiodol is a special type of treatment used for liver cancer that cannot be removed with surgery. This therapy involves injecting a radioactive substance directly into the liver. The goal is to target and destroy cancer cells while minimizing damage to healthy tissue. The radioactive material helps to shrink the tumor and slow down its growth, providing a treatment option for patients who have limited choices due to the inoperable nature of their cancer.

Investigated diseases:

Hepatocellular carcinoma – Hepatocellular carcinoma is a type of liver cancer that originates in the hepatocytes, the main type of liver cell. It typically develops in the context of chronic liver disease, often related to hepatitis or cirrhosis. The disease progresses as the cancerous cells multiply and form a tumor, which can disrupt liver function. As the tumor grows, it may invade nearby blood vessels and spread to other parts of the liver or beyond. Symptoms may include abdominal pain, weight loss, and jaundice, although they often appear in advanced stages. The progression of the disease can lead to further complications, such as liver failure or metastasis to other organs.

Trial ID:
2023-503341-60-00
Protocol code:
2017-1-14-010
Trial Phase:
Therapeutic exploratory (Phase II)

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