Study on Nivolumab with Drug Combination for Patients with Intermediate Stage Liver Cancer

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What is this study about?

This clinical trial is focused on studying treatments for intermediate stage hepatocellular carcinoma (HCC), a type of liver cancer. The study will explore the effectiveness of a medication called nivolumab, also known by its code name BMS936558, in combination with a procedure called Transarterial Chemoembolization (TACE) or Transarterial Embolization (TAE). These procedures involve delivering chemotherapy or blocking blood supply directly to the liver tumor. The trial will also involve other medications, including doxorubicin, epirubicin, idarubicin, mitomycin, cisplatin, and ethyl esters of iodised fatty acids from poppyseed oil.

The purpose of the study is to evaluate how well nivolumab works when used with TACE or TAE in patients with intermediate stage HCC. The study will be conducted in two phases. In the first phase, the focus will be on assessing the effectiveness of the treatment combination. In the second phase, the study will compare the survival rates of patients receiving the combination treatment to those receiving other treatments. Participants will receive the treatments through injections or infusions over a period of time, and their health will be monitored throughout the study.

During the trial, participants will undergo regular assessments to track the progress of their condition and any side effects they may experience. The study aims to provide valuable information on the potential benefits of combining nivolumab with TACE or TAE for treating intermediate stage HCC, ultimately contributing to improved treatment options for patients with this type of liver cancer.

1 joining the study

Upon joining the study, a confirmation of eligibility is required. This includes a diagnosis of intermediate stage hepatocellular carcinoma (HCC) and meeting specific health criteria.

A negative pregnancy test is necessary for women of child-bearing potential. Both men and women must use adequate contraception during the study and for a specified period after treatment.

2 treatment initiation

The treatment involves the administration of nivolumab in combination with TACE/TAE. Nivolumab is given as an intravenous infusion.

The specific dosage and frequency of nivolumab will be determined by the study protocol and the healthcare team.

3 treatment with TACE/TAE

TACE (Transarterial Chemoembolization) or TAE (Transarterial Embolization) procedures are performed. These involve the injection of chemotherapy drugs directly into the liver.

The drugs used may include doxorubicin, epirubicin, idarubicin, mitomycin, cisplatin, and ethyl esters of iodised fatty acids from poppyseed oil.

4 monitoring and follow-up

Regular monitoring is conducted to assess the response to treatment and any side effects. This includes imaging tests like CT scans or MRIs.

The primary focus is on the time to progression of the disease and overall survival rates.

5 completion of treatment

The study aims to evaluate the efficacy of the treatment over a period that may extend until September 2026.

After completing the treatment, follow-up visits are scheduled to monitor long-term health and any delayed side effects.

Who Can Join the Study?

Must have a confirmed diagnosis of Hepatocellular carcinoma (HCC), which is a type of liver cancer, and at least one measurable tumor as seen on a CT-scan or MRI.
Must have a HAP score of A, B, or C. This is a score used to assess liver function and cancer stage.
Must not have any conditions that prevent the use of T-cell checkpoint inhibitor therapy. This includes not using certain immune-suppressing drugs, not having had an organ transplant, and not having active autoimmune diseases. Some conditions like type I diabetes or certain skin disorders are allowed if they don’t need systemic treatment.
Women who can have children must have a negative pregnancy test before joining the study. Both men and women must use effective birth control during the study and for a period after treatment ends (5 months for women, 7 months for men).
Must provide written informed consent to participate in the study.
Must be at least 16 years old and have an estimated life expectancy of at least 3 months.
Must have an ECOG performance status of 0-1, which means being fully active or having some symptoms but being able to carry out light work.
Must have adequate blood health, including hemoglobin levels of at least 9g/L, a certain number of neutrophils (a type of white blood cell), and a platelet count of at least 60×10⁹/L.
Must have liver function tests within certain limits, including bilirubin levels of 50 micromoles per liter or less, and AST, ALT, and ALP levels no more than 5 times the upper limit of normal.
Must have adequate kidney function, with creatinine levels no more than 1.5 times the upper limit of normal.
Must have an INR (a measure of blood clotting) of 1.6 or less.
Must have a Child-Pugh score of A, which is a score used to assess the severity of liver disease.

Who Cannot Join the Study?

Patients with other types of cancer besides intermediate stage hepatocellular carcinoma cannot participate. Hepatocellular carcinoma is a type of liver cancer.
Patients who have had previous treatments that might interfere with the study results are not eligible.
Individuals with severe or uncontrolled medical conditions that could affect their safety or the study outcomes are excluded.
Pregnant or breastfeeding women cannot take part in the study.
Patients who are unable to follow the study procedures or attend the required visits are not eligible.
Individuals with a history of allergic reactions to the study medications are excluded.
Patients who are participating in another clinical trial at the same time are not allowed to join this study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Hopital Beaujon	Clichy	France
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
Cgohvy Hugyycfsdnn Uhyyyvnnunosv Rcoip	Reims	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	12.10.2022

Trial locations

Investigated drugs:

Nivolumab is a medication used in this trial to help the body’s immune system fight cancer cells. It is a type of immunotherapy known as a checkpoint inhibitor, which works by blocking a protein that prevents the immune system from attacking cancer cells. In this trial, nivolumab is being tested in combination with other treatments to see if it can improve outcomes for patients with intermediate-stage liver cancer.

TACE/TAE stands for Transarterial Chemoembolization/Transarterial Embolization. These are procedures used to treat liver cancer by delivering chemotherapy or blocking the blood supply directly to the tumor. This helps to shrink the tumor and limit its growth. In this trial, TACE/TAE is combined with nivolumab to evaluate if the combination is more effective than the standard treatment alone.

Investigated diseases:

Hepatocellular carcinoma

Intermediate stage Hepatocellular carcinoma – This is a type of liver cancer that occurs when malignant cells form in the tissues of the liver. In the intermediate stage, the cancer has typically grown larger or spread to nearby blood vessels but has not yet spread to distant parts of the body. Patients may experience symptoms such as abdominal pain, weight loss, or jaundice. The disease progresses as the tumor grows and potentially affects liver function. It is often associated with underlying liver conditions such as cirrhosis or hepatitis. The progression can vary, and monitoring is essential to manage the disease effectively.

Trial ID:

2024-513882-38-00

Protocol code:

ISRCTN12053408

NCT ID:

NCT04268888

Trial Phase:

Therapeutic use (Phase IV)

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Study on Nivolumab with Drug Combination for Patients with Intermediate Stage Liver Cancer

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