Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Efficacy evaluation of 188Re-SSS lipiodol Selective Internal Radiation Therapy of non operable hepatocellular carcinoma patients, a phase II study

This research study is investigating a new treatment called 188Re-SSS Lipiodol for a type of liver cancer that can't be treated with surgery. This treatment involves delivering a substance directly to the liver. The main goal is to find out how effective this treatment is at shrinking the cancer. Researchers will be looking at how well tumours respond within the first six months, and regularly checking for tumour growth. They will also track how long patients live without their cancer getting worse, and their overall survival time. Additionally, they will monitor changes in a specific blood marker related to liver cancer. This is a Phase II study, meaning it's an early-stage trial focusing on the treatment's effectiveness and safety.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Centre De Lutte Contre Le Cancer Eugene Marquis

Enrolment target

Start

05 Jul 2023

non-operable hepatocellular carcinoma

What is this study about?

This study is looking at a new treatment for a type of liver cancer called hepatocellular carcinoma. This specific cancer is 'non-operable,' meaning it can't be removed with surgery. The new treatment being tested is called 188Re-SSS Lipiodol. It's a special kind of internal radiation therapy, which means radioactive medicine is delivered directly to the liver.

The main idea behind this treatment is to target the cancer cells in the liver with radiation, hopefully shrinking the tumours or stopping them from growing. Researchers want to see how well this treatment works. They will be carefully measuring things like how much the tumours shrink over several months, how long it takes before the cancer grows again, and how long people live after having this treatment. They will also look at a blood test for a marker called AFP, which can be linked to liver cancer, to see if its levels improve.

This is a 'Phase II' study. This means it's an early step in testing a new treatment. Treatments going through Phase II studies have usually been shown to be safe in earlier tests, and now researchers want to learn more about how well they work and if they have any side effects. The results of this study will help doctors understand if 188Re-SSS Lipiodol could be a good treatment option for patients with this type of liver cancer in the future.

Key takeaways

Tests a new liver cancer treatment (188Re-SSS Lipiodol).
For liver cancer that cannot be removed by surgery.
Aims to see if the treatment shrinks tumours and improves health.
Regular scans and blood tests are part of the study.
Participation involves treatment and follow-up for up to 2 years.
This is an early-stage (Phase II) study to learn more about the treatment.

Who may be eligible?

To be part of this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

However, it's specifically for people who have hepatocellular carcinoma, which is a type of liver cancer, and whose cancer cannot be removed by surgery. There will be other specific medical checks to make sure this treatment is suitable and safe for you, as not everyone with this condition can take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have hepatocellular carcinoma (a type of liver cancer)?
Has your doctor told you your liver cancer cannot be removed by surgery?
Are you able to attend regular hospital appointments for follow-up over up to 2 years?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve receiving the 188Re-SSS Lipiodol treatment. After the treatment, you would have regular check-ups and assessments. These would likely include scans (like CT or MRI) to see how your liver cancer is responding, and blood tests to check your general health and levels of certain cancer markers.

These check-ups would happen at specific times, for example, at one month, three months, and then every three months after your treatment for up to two years. The total duration of your participation in the study, including follow-up, could be up to 24 months (two years).

Potential risks and benefits

Like all medical treatments, there could be potential benefits and potential risks with 188Re-SSS Lipiodol. The potential benefit is that the treatment might shrink your liver tumour, slow down its growth, or improve your quality of life, as seen in previous early studies. However, it's also possible that the treatment won't work for you, or you might experience side effects, which the study will carefully monitor. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is hepatocellular carcinoma?

It's a type of liver cancer that starts in the main cells of the liver.

What does 'non-operable' mean?

It means the cancer cannot be completely removed through surgery, often because of its size, location, or spread.

What is 188Re-SSS Lipiodol?

It's a special liquid that carries a small amount of radiation directly into the liver to target cancer cells.

What is a 'Phase II study'?

It means it's an early stage of clinical research where doctors are testing how well a new treatment works and continue to check for safety.

Will this treatment cure my cancer?

The goal of this study is to see how well the treatment shrinks tumours or slows their growth. Cure is a very high bar, and this study tries to understand treatment effectiveness.