Study of Tislelizumab immunotherapy in patients with liver cancer (hepatocellular carcinoma) who have moderately impaired liver function (Child-Pugh B)

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What is this study about?

This study focuses on patients with Hepatocellular Carcinoma (liver cancer) who have moderately altered liver function. The research will test a medication called tislelizumab, which is given through an intravenous infusion. This medication belongs to a group of drugs called immunotherapy, which works by helping the body’s immune system fight cancer cells.

The purpose of this research is to determine how well tislelizumab works in treating liver cancer patients whose liver function is moderately impaired. During the study, participants will receive tislelizumab infusions at regular intervals. The maximum treatment period can last up to 24 months, with patients receiving up to 200 mg of the medication per day.

Throughout the study, patients will have their health monitored through regular medical check-ups and imaging tests to evaluate how their cancer responds to the treatment. The study will also track patients’ overall health status and quality of life during the treatment period. Patients who participate in this research will have their condition monitored for several months after completing the treatment.

1 Initial treatment preparation

You will receive tislelizumab (Tevimbra) through an intravenous infusion (directly into your vein).

A pregnancy test is required within 7 days before starting treatment if you are a woman who can become pregnant.

Blood tests will be performed to check your organ function before treatment begins.

2 Treatment administration

You will receive regular infusions of tislelizumab at the treatment center.

During treatment, your response to therapy will be monitored using imaging scans.

Your liver function will be regularly checked through blood tests.

You will complete quality of life questionnaires during your visits.

3 Safety monitoring

Your doctor will monitor any side effects throughout the treatment period.

If you experience serious side effects before the second injection, your treatment may need to be stopped.

Regular blood tests will continue to check your liver and kidney function.

4 Follow-up period

After completing treatment, you will be monitored for an additional 3 months.

During this period, any side effects will continue to be tracked and managed.

You must use effective birth control during treatment and for 120 days after the last dose.

5 Long-term monitoring

Your health status will be monitored until the study ends in December 2028.

Regular imaging scans will track your liver cancer response to treatment.

Your overall survival and disease progression will be monitored throughout the study period.

Who Can Join the Study?

Must be 18 years or older
Must have measurable liver cancer that can be evaluated through medical imaging
Women who can become pregnant must:
- Use effective birth control during the study and for 120 days after the last treatment
- Have a negative pregnancy test within 7 days before starting treatment
Men who are not sterile must use effective birth control during the study and for 120 days after the last treatment
Must sign an informed consent form before any study procedures begin
Must agree to provide tumor and blood samples for research
Must have health insurance or social security coverage
Must agree not to donate sperm or eggs during treatment and for 120 days after
Must have liver cancer confirmed by:
- Tissue examination (biopsy) OR
- Typical imaging findings when biopsy cannot be safely performed
Must have adequate organ function including:
- Sufficient blood cell counts
- Adequate kidney function
- Acceptable liver function tests
Must be able to perform daily activities with minimal assistance (ECOG score of 2 or less)
Must have specific liver function measurements that fall within Child-Pugh B and ALBI grade 1 or 2 ranges
May have had previous treatment with certain cancer medications (tyrosine kinase inhibitors) but not immunotherapy

Who Cannot Join the Study?

History of autoimmune disease requiring systemic treatment
Active or chronic hepatitis B infection
Active hepatitis C infection requiring antiviral therapy
Previous treatment with any immunotherapy (medications that help your immune system fight cancer)
Presence of brain metastases (cancer that has spread to the brain)
Child-Pugh C liver function (severe liver dysfunction)
ALBI grade 3 liver function (severe impairment of liver function)
Active or untreated esophageal varices (enlarged veins in the food pipe)
Significant heart conditions including heart failure or recent heart attack
Active or uncontrolled infections
Other active cancers requiring treatment
Pregnancy or breastfeeding
Known allergy or sensitivity to study medications
Mental conditions that could interfere with study participation
Any condition that the study doctor believes would make participation unsafe

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Hôpital Avicenne	Bobigny	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Hopital Beaujon	Clichy	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Hopital Saint Joseph	Marseille	France
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
Cojajx Huamhrtnysb Ruykaick Dwdtpygfhzmxtb	Angers	France
Ctm Cgvio Rqhessnafqa	Lyon	France
Iutokixs Prwfwethtwgzucu Ceewgh Cqegvx	Marseille	France
Hzrcqzin Unvnkrimbbtbjv Srksuoooqj &qvxyvo Hduprcs dl Hwroxewlnbi	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	11.10.2023

Trial locations

Investigated drugs:

Tislelizumab

Tislelizumab is a medication that belongs to a group called PD-1 inhibitors. It works by helping your immune system fight against liver cancer cells. This medication is given as a treatment for people who have a specific type of liver cancer called hepatocellular carcinoma, particularly in patients who have certain liver function characteristics. The medication is administered through an intravenous infusion (through a vein).

Investigated diseases:

Hepatocellular carcinoma

Hepatocellular Carcinoma (HCC) – A primary type of liver cancer that begins in the main type of liver cells (hepatocytes). The disease develops when liver cells develop changes in their DNA, causing the cells to grow and multiply uncontrollably. These abnormal cells continue living when other cells would naturally die, forming a tumor that can expand beyond the liver. HCC often occurs in people who have chronic liver diseases, such as cirrhosis. The condition can affect liver function, which is measured using classifications like Child-Pugh and ALBI grades.

Trial ID:

2024-516443-57-00

Protocol code:

UC-GIG-2003

NCT ID:

NCT05622071

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Tislelizumab immunotherapy in patients with liver cancer (hepatocellular carcinoma) who have moderately impaired liver function (Child-Pugh B)

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?