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Study on Nivolumab with Drug Combination for Patients with Intermediate Stage 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 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.

The research process

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

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

12 criteria

  • 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 60x109/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 trial?

7 criteria

  • 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.
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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.

What is already known about the treatment

Nivolumab – Nivolumab is administered as an intravenous infusion, typically given in a clinical setting under the supervision of healthcare professionals. It is currently being studied in clinical trials for its effectiveness in treating intermediate-stage hepatocellular carcinoma (HCC) when combined with transarterial chemoembolization (TACE) or transarterial embolization (TAE). Nivolumab is primarily used for its immune-boosting properties, helping the body's immune system recognize and attack cancer cells. It works by blocking a protein called PD-1 on immune cells, which can otherwise inhibit the immune response against cancer. Nivolumab is classified as an immune checkpoint inhibitor, a type of immunotherapy.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-513882-38-00Protocol codeISRCTN12053408Estimated enrolment101 patientsSponsorThe Clatterbridge Cancer Centre NHS Foundation Trust

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