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

Verified siteRegistered drugNo placebo

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What is this trial about?

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

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

17 criteria

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 trial?

15 criteria

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

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Verified sites

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

CHU Croix Rousse-Lyon
Verified
Lyon, France
CHU Grenoble Alpes
Verified
La Tronche, France
Centre De Lutte Contre Le Cancer Eugene Marquis
Verified
Rennes, France

Trial locations

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Investigated drugs

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).

Tislelizumab

What is already known about the treatment

Tislelizumab – A monoclonal antibody medication administered through intravenous infusion, which belongs to the class of immune checkpoint inhibitors targeting PD-1 (programmed cell death protein 1). The drug works by blocking the interaction between PD-1 and its ligands, thereby restoring T-cell immune response against cancer cells, particularly in the treatment of Hepatocellular Carcinoma (HCC). Currently undergoing clinical trials for patients with liver cancer who have specific liver function scores (Child-Pugh B and ALBI grade 1 or 2), this immunotherapy treatment represents a promising approach for patients who may or may not have received prior treatment with tyrosine kinase inhibitors.

Investigated diseases

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.