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Study of Pembrolizumab as Additional Treatment for Patients with Liver Cancer (Hepatocellular Carcinoma) After Surgery or Local Ablation

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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 (a type of liver cancer) who have had complete removal of visible cancer through surgery or local treatment. The study tests whether additional treatment with pembrolizumab (also known as KEYTRUDA) can help prevent cancer from returning, compared to a placebo.

The medication pembrolizumab is given through an intravenous infusion (a drip into a vein). Participants will receive either pembrolizumab or placebo every three weeks. The maximum single dose is 200 milligrams, and treatment can continue for up to 51 weeks. Neither the doctors nor the participants will know which treatment is being given during the study.

The study aims to determine if pembrolizumab can extend the time before cancer returns and improve overall survival in patients who have had their liver cancer successfully treated. The medication works by helping the body's immune system fight cancer cells. Throughout the study, doctors will monitor participants' health and any side effects they may experience.

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

    Initial eligibility confirmation

    Your eligibility will be confirmed through scans (CT of chest, special CT or MRI of abdomen and pelvis) at least 4 weeks after your surgical procedure or local ablation

    Your liver function will be checked to confirm Child-Pugh class A liver score (5-6 points)

    Your alpha fetoprotein (AFP) level must be below 400 ng/mL

    Your physical condition will be assessed using the ECOG performance status scale, which must be 0 or 1

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either pembrolizumab (KEYTRUDA) or placebo

    Neither you nor your doctor will know which treatment you are receiving

    Treatment must begin within 12 weeks of your surgical procedure or local ablation

  3. Step 3

    Treatment administration

    You will receive treatment through intravenous infusion

    The medication (KEYTRUDA) concentration is 25 mg/mL in solution form

    If you are in the placebo group, you will receive normal saline solution

  4. Step 4

    Monitoring and assessment

    Your health status will be regularly monitored for any side effects

    You will complete quality of life questionnaires (EORTC QLQ-C30, EORTC QLQ-HCC18, EQ-5D-5L) to assess your well-being

    Regular scans will be performed to check for any disease recurrence

    Your overall survival will be monitored throughout the study period

  5. Step 5

    Study duration

    The study will continue until August 31, 2029

    Your participation may end earlier if you experience significant side effects or if your disease returns

Who can join the trial?

12 criteria

  • Must have a diagnosis of liver cancer (HCC) confirmed by imaging tests and/or tissue examination
  • If having surgery, must provide a tumor tissue sample during screening period
  • Must have normal functioning organs
  • Must have imaging scans (chest CT, special abdominal CT or MRI, and pelvis imaging) showing no cancer at least 4 weeks after surgery or ablation treatment. Must join the study within 12 weeks after these procedures
  • Must show no signs of cancer on imaging tests before entering the study
  • Must be able to perform daily activities with minimal or no assistance (ECOG score of 0 or 1) within 7 days before starting treatment
  • Must have good liver function (Child-Pugh class A score between 5-6 points) within 7 days before starting treatment
  • Must have a liver protein level (alpha fetoprotein or AFP) below 400 ng/mL within 28 days before starting treatment
  • Must have controlled hepatitis B infection
  • Must have recovered from any complications from previous surgery or ablation treatment
  • For women: must not be pregnant or breastfeeding, and either:
    • Be unable to become pregnant, or
    • Use effective birth control or abstain from sexual activity (must have negative pregnancy test within 72 hours before starting treatment)

Who cannot join the trial?

15 criteria

  • History of previous liver transplantation or currently on waiting list for transplant
  • Active or chronic hepatitis B infection without appropriate antiviral treatment
  • Known HIV infection (Human Immunodeficiency Virus)
  • Currently receiving treatment for other types of cancer
  • Severe heart conditions, including heart failure or recent heart attack (within last 6 months)
  • Severe kidney problems requiring dialysis
  • Uncontrolled high blood pressure
  • Active substance abuse or alcohol dependency within the past year
  • Pregnant or breastfeeding women
  • Mental conditions that could interfere with following study procedures
  • Participation in another clinical trial within the last 30 days
  • Known allergies to the study medications
  • Major surgery planned during the study period
  • Severe liver disease beyond the condition being studied
  • Unable to provide informed consent
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Investigated drugs

Pembrolizumab (also known as MK-3475) is a medication that helps the immune system fight cancer cells. It belongs to a class of drugs called immunotherapy. This medication works by blocking a protein called PD-1 on immune cells, which helps these cells recognize and attack cancer cells more effectively. In this trial, it is being studied as a treatment after surgery or local ablation in patients with liver cancer (hepatocellular carcinoma) who have shown a complete response to initial treatment.

What is already known about the treatment

Pembrolizumab – A prescription immunotherapy medication administered through intravenous infusion, commonly known under the brand name Keytruda, which belongs to the class of PD-1 inhibitors. This monoclonal antibody works by helping the immune system detect and fight cancer cells by blocking the PD-1 pathway that cancer cells use to hide from immune cells. In this clinical trial, it is being studied as an adjuvant therapy for hepatocellular carcinoma (liver cancer) in patients who have had complete tumor removal through surgery or local ablation, with the goal of preventing cancer recurrence. The medication has already proven effective in treating various types of cancer and has received multiple FDA approvals for different cancer indications.

Investigated diseases

Hepatocellular Carcinoma (HCC) – A primary type of liver cancer that begins in the main type of liver cells (hepatocytes). The disease typically develops in people with chronic liver diseases, such as cirrhosis. HCC often starts as a single tumor that grows larger or as many small cancer nodules throughout the liver. The cancer can spread within the liver and may eventually affect other organs. The condition usually progresses gradually, with changes in liver function occurring over time. The liver may become enlarged as the disease advances.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501971-24-00Protocol codeMK-3475-937Estimated enrolment950 patientsSponsorMerck Sharp & Dohme LLC

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