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Study on the Effectiveness and Safety of TPST-1120 and Drug Combination for Patients with Advanced Liver Cancer

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 clinical trial is focused on studying treatments for advanced liver cancers. The study will explore the effectiveness and safety of various combinations of treatments that involve immunotherapy, which is a type of treatment that helps the body's immune system fight cancer. The medications being tested include TPST-1120, a capsule taken orally, which works by blocking a specific protein in the body; RoActemra, Tiragolumab, RO7790118, RO7791094, RO7247669, Tecentriq, Avastin, and ADG126, all of which are given as solutions for infusion, meaning they are administered directly into the bloodstream through a vein.

The purpose of this study is to evaluate how well these treatment combinations work in shrinking or controlling the cancer and to assess their safety. Participants will receive either the treatment combinations or a placebo. The study will involve regular visits to the clinic for treatment administration and monitoring. During these visits, doctors will check the participants' health, perform necessary tests, and monitor any side effects. The study aims to provide valuable information on the potential benefits and risks of these new treatment combinations for patients with advanced liver cancers.

Throughout the study, participants will be closely monitored by healthcare professionals to ensure their safety and well-being. The study will continue for several years, allowing researchers to gather comprehensive data on the long-term effects and benefits of the treatments. This research is crucial in the ongoing effort to find more effective treatments for advanced liver cancers and improve the quality of life for those affected by this disease.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, health status, and type of liver cancer.
A performance status assessment is conducted to ensure the ability to participate in the trial.
Step 2
Initial assessment
An initial assessment is performed, including a review of medical history and a physical examination.
Baseline measurements of vital signs and laboratory tests are taken to establish a starting point for the study.
Step 3
Treatment assignment
Participants are randomly assigned to different treatment groups, each receiving a combination of immunotherapy-based treatments.
The specific treatment combination is determined by the study protocol.
Step 4
Treatment administration
Treatment involves the administration of various medications, including TPST-1120 (oral capsules), RoActemra (intravenous infusion), and Tiragolumab (intravenous infusion).
Other medications such as Tecentriq and Avastin are also administered via intravenous infusion.
The frequency and duration of each medication are specified in the study protocol.
Step 5
Ongoing monitoring
Regular monitoring is conducted to assess the effectiveness and safety of the treatment.
This includes periodic evaluations of vital signs, laboratory tests, and imaging studies to track changes in the condition.
Step 6
Follow-up assessments
Follow-up assessments are scheduled at specific intervals to evaluate the response to treatment.
These assessments help determine the overall response rate and any changes in the disease status.
Step 7
Completion of study
Upon completion of the study, a final assessment is conducted to evaluate the overall outcomes.
Participants may receive information about the results and any potential next steps in their treatment plan.

Who can join the trial?

8 criteria

Must be **18 years or older**.
Have an **Eastern Cooperative Oncology Group (ECOG) Performance Status** of 0 or 1. This is a scale used to assess how well a person can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but nearly fully active.
Have **locally advanced or metastatic and/or unresectable hepatocellular carcinoma (HCC)**. This means the liver cancer has spread or cannot be removed by surgery. The diagnosis must be confirmed by a tissue sample or specific criteria for liver disease in patients with liver scarring (cirrhosis).
Have a **Child-Pugh class A**. This is a scoring system to assess the severity of liver disease, with class A indicating the least severe disease.
The disease cannot be treated with surgery or local therapies aimed at curing it.
No previous **systemic treatment** for HCC. This means no treatments that affect the entire body, including experimental drugs.
Have a **life expectancy of at least 3 months** as judged by the doctor.
A tumor sample must be available for testing specific proteins or markers, such as **PD-L1**, which are used to help guide treatment decisions.

Who cannot join the trial?

10 criteria

Patients with other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had another type of cancer within the last 5 years, except for certain skin cancers or in situ cervical cancer, which is a very early stage of cervical cancer.
Patients who have had a severe allergic reaction to similar treatments in the past.
Patients who are currently participating in another clinical trial.
Patients who have an active infection that requires treatment.
Patients with a history of certain heart conditions that could pose a risk during the study.
Patients who have received certain treatments for cancer within a specific time frame before the study starts.
Patients with uncontrolled high blood pressure.
Patients with a history of drug or alcohol abuse that could affect their ability to participate in the study.

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Verified sites

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

Verified
Assistance Publique Hopitaux De Marseille
Marseille, France
Verified
Centr Georges Francois Leclerc
Dijon, France
Verified
Centre De Lutte Contre Le Cancer Eugene Marquis
Rennes, France

Trial locations

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Investigated drugs

Atezolizumab
is an immunotherapy medication used in this trial. It works by helping the immune system recognize and attack cancer cells more effectively. It is often used in combination with other treatments to enhance its effectiveness against advanced liver cancers.
Bevacizumab
is another medication involved in the trial. It is designed to slow the growth of new blood vessels that tumors need to grow and spread. By inhibiting these blood vessels, bevacizumab can help to starve the cancer cells and limit their growth.
Tiragolumab
is an investigational drug being tested in this study. It is a type of immunotherapy that targets specific proteins on cancer cells, aiming to boost the body's immune response against the cancer.
Cabozantinib
is a medication that targets multiple pathways involved in cancer cell growth and spread. It is used to treat advanced liver cancers by interfering with the cancer cells' ability to grow and divide.
Durvalumab
is an immunotherapy drug that helps the immune system detect and fight cancer cells. It is used in combination with other treatments to improve the body's natural defenses against liver cancer.
Tremelimumab
is another immunotherapy medication in the trial. It works by blocking certain proteins that prevent the immune system from attacking cancer cells, thereby enhancing the immune response against the tumor.

Tpst-1120

What is already known about the treatment

Immunotherapy-Based Treatment Combinations – These treatments are administered intravenously, meaning they are given directly into a vein. They are currently being studied in clinical trials for their effectiveness and safety in treating advanced liver cancers. The main therapeutic indication is to improve the response rate in patients with this type of cancer. At the molecular level, these treatments work by stimulating the body's immune system to recognize and attack cancer cells more effectively. They are classified under immunotherapy, which is a type of cancer treatment that helps the immune system fight cancer.

Investigated diseases

Advanced Liver Cancer – This is a stage of liver cancer where the disease has progressed beyond the initial stages and may have spread to other parts of the body. It often begins in the liver cells and can grow into nearby tissues or organs. As the cancer advances, it can cause symptoms such as weight loss, loss of appetite, and abdominal pain. The progression of the disease can lead to liver dysfunction, affecting the body's ability to process nutrients and filter toxins. Advanced liver cancer may also result in jaundice, which is a yellowing of the skin and eyes due to liver impairment. The disease can further progress to cause fluid accumulation in the abdomen, known as ascites.