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Study on Regorafenib and Pembrolizumab 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 a type of liver cancer known as intermediate-stage hepatocellular carcinoma (HCC). The study is comparing two different treatment approaches for this condition. One approach involves using a combination of two medications: pembrolizumab and regorafenib. Pembrolizumab, also known by its code name MK-3475, is a type of medication called a monoclonal antibody, which helps the immune system fight cancer. Regorafenib, also known as BAY 734506, is a chemical compound that works by blocking certain proteins that promote cancer cell growth. The other approach being studied is a type of local treatment called transarterial chemoembolization (TACE) or transarterial radioembolization (TARE), which targets the liver directly.

The purpose of this study is to compare the effectiveness and safety of the medication combination (pembrolizumab and regorafenib) with the local treatments (TACE or TARE) in patients with intermediate-stage HCC. Participants in the study will be randomly assigned to receive either the medication combination or one of the local treatments. The study will monitor the progress of the disease and any side effects experienced by the participants over a period of time.

Throughout the study, participants will receive regular check-ups and assessments to track their health and the impact of the treatment. The study aims to provide valuable information on which treatment approach may be more beneficial for patients with this type of liver cancer. The trial is expected to continue until 2027, with recruitment starting in 2024.

The research process

The trial runs in 6 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, the patient must have signed and dated the Patient Informed Consent Form (PICF).

    The patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm eligibility, including a diagnosis of intermediate-stage hepatocellular carcinoma (HCC) with beyond up-to-7 criteria.

    Women of childbearing potential must have a confirmed negative serum pregnancy test and use highly-effective contraceptive methods.

  3. Step 3

    Randomization

    The patient will be randomly assigned to one of two treatment groups: systemic therapy with regorafenib and pembrolizumab, or locoregional therapy with transarterial chemoembolization (TACE) or transarterial radioembolization (TARE).

  4. Step 4

    Treatment administration

    For those receiving systemic therapy, pembrolizumab will be administered as an intravenous infusion. The specific dosage and frequency will be determined by the study protocol.

    Additionally, regorafenib will be taken orally in the form of film-coated tablets. The dosage and frequency will also follow the study protocol.

  5. Step 5

    Ongoing assessments

    Throughout the trial, the patient's progress will be monitored through regular assessments, including imaging tests like CT or MRI to measure disease status.

    The primary goal is to evaluate progression-free survival (PFS), which is the time from randomization until disease progression or death.

  6. Step 6

    Completion of trial

    The trial is estimated to end by April 30, 2027. The patient's participation will continue until the trial's conclusion or until specific criteria are met, such as disease progression or unacceptable side effects.

Who can join the trial?

18 criteria

  • Sign and date the Patient Informed Consent Form (PICF).
  • Be willing and able to attend scheduled visits, follow treatment plans, and undergo laboratory tests and other trial procedures.
  • Women who can have children must have a confirmed negative blood pregnancy test.
  • Use highly effective birth control methods if you are a woman who can have children or a man.
  • If you have hepatitis C virus (HCV) or hepatitis B virus (HBV) infection, you may be eligible if you meet specific criteria outlined in the study protocol.
  • Be at least 18 years old at the time of signing the PICF.
  • Have a confirmed diagnosis of HCC (hepatocellular carcinoma, a type of liver cancer).
  • Have intermediate-stage HCC, which means:
    • The cancer is multinodular and located in the liver.
    • No evidence of MVI (macrovascular invasion) or EHS (extrahepatic spread).
    • The cancer cannot be treated with curative methods.
    • Child-Pugh Class A, which is a way to assess liver function.
    • ECOG PS (Eastern Cooperative Oncology Group Performance Status) of 0 or 1, which measures your ability to perform daily activities.
    • ALBI grade 1 or 2, which is another way to assess liver function.
    • Meet the "beyond up-to-seven criteria," which is a specific classification for liver cancer.
    • The disease can be treated with TACE (transarterial chemoembolization) or TARE (transarterial radioembolization) and there is no reason to avoid these treatments.
    • Have measurable disease by CT (computed tomography) or MRI (magnetic resonance imaging) according to RECIST 1.1, which is a standard way to measure cancer response to treatment.
    • Have not received any prior systemic therapy or local-regional therapy for HCC.
    • Have adequate blood and organ function.

Who cannot join the trial?

8 criteria

  • Patients with a different stage of liver cancer than the one specified in the study.
  • Patients who do not meet the specific criteria related to the size and number of liver tumors.
  • Patients who have other serious health conditions that could interfere with the study.
  • Patients who are unable to follow the study procedures or attend required visits.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies or reactions to the study medications.
  • Patients who have a history of certain medical conditions that could affect the study results.
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Investigated drugs

  • Regorafenib

    is a medication used in this trial to treat liver cancer. It works by blocking certain proteins that help cancer cells grow and spread. This medication is taken by mouth and is part of the systemic therapy being tested.

  • Pembrolizumab

    is an immunotherapy drug used in this trial. It helps the body's immune system recognize and attack cancer cells. Pembrolizumab is given as an injection and is combined with regorafenib in the systemic therapy being evaluated.

  • Transarterial Chemoembolization (TACE)

    is a locoregional therapy used in this trial. It involves delivering chemotherapy directly to the liver tumor through the blood vessels, while also blocking the blood supply to the tumor to help shrink it.

  • Transarterial Radioembolization (TARE)

    is another locoregional therapy option in this trial. It involves injecting tiny radioactive beads into the blood vessels that supply the liver tumor, delivering radiation directly to the cancer cells to destroy them.

What is already known about the treatment

  • Regorafenib

    This medication is taken orally in the form of tablets. It is currently used in medical practice and literature for treating certain types of cancer, including liver cancer. The main therapeutic indication for regorafenib is intermediate-stage hepatocellular carcinoma that exceeds specific criteria. At the molecular level, regorafenib works by inhibiting multiple protein kinases, which are involved in tumor growth and angiogenesis. It is classified as a multikinase inhibitor.

  • Pembrolizumab

    This medication is administered through intravenous infusion. It is widely recognized in medical literature and practice for its role in cancer treatment. Pembrolizumab is primarily indicated for intermediate-stage hepatocellular carcinoma among other cancers. Its mechanism of action involves blocking the PD-1 pathway, which helps the immune system detect and fight cancer cells more effectively. Pembrolizumab is classified as an immune checkpoint inhibitor.

Investigated diseases

Intermediate-stage hepatocellular carcinoma – This is a type of liver cancer that occurs when cancerous cells form in the tissues of the liver. In the intermediate stage, the cancer has progressed beyond the early stages but has not yet spread to distant parts of the body. It is characterized by multiple tumors in the liver, which may be large in size. The disease progresses as the tumors grow and potentially affect liver function. The "beyond up-to-7 criteria" refers to a specific classification used to assess the extent and severity of the cancer. As the disease advances, it may lead to further complications related to liver function and overall health.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501969-42-00Protocol codeTRIO041Estimated enrolment597 patientsSponsorTranslational Research In Oncology

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