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Liver cancer drug combo put to the test – but trial stops early

NCT ID NCT04777851

Disease control Sponsor: Translational Research in Oncology Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial compared a combination of two drugs (regorafenib and pembrolizumab) with standard locoregional therapies (TACE or TARE) as a first treatment for intermediate-stage liver cancer that has spread beyond certain limits. The study aimed to enroll about 496 people but was terminated early after only 45 participants. Researchers were looking at how long patients lived without their cancer getting worse.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
regorafenib and pembrolizumab
What this could lead to
If successful, this combination could offer a new first-line treatment option for people with intermediate-stage liver cancer that is not suitable for surgery.
What could go wrong
The trial was terminated early and enrolled only 45 of a planned 496 participants, so results are limited. Both drug combinations carry risks of serious side effects, and it is unclear if the experimental arm is better than existing therapies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

45 people

The number who actually took part.

Started

Oct 2023

Finished

Feb 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Signed and dated Patient Informed Consent Form (PICF) * ≥ 18 years-old at the time of PICF signature * Confirmed diagnosis of HCC * Intermediate-stage HCC, defined as follows: * Multinodular HCC localized to the liver * No evidence of MVI or EHS * Not amenable to curative treatment * Child-Pugh Class A * ECOG PS 0 or 1 * ALBI grade 1 or 2 * Beyond up-to-seven criteria * Disease amenable to TACE or TARE and no contradiction to intra-arterial treatment * Measurable disease by CT or MRI as per RECIST 1.1 * No prior systemic therapy or loco-regional therapy for HCC * Adequate hematologic and organ function * Willing and able to comply with scheduled visits, treatment plans, laboratory tests and other trial procedures * Women of childbearing potential (CBP) must have confirmed negative serum pregnancy test * Use of highly-effective contraceptive methods in women of CBP and men * Patients with hepatitis C virus (HCV) or hepatitis B virus (HBV) infection are eligible if they meet criteria as defined within the protocol Exclusion Criteria: * No measurable tumor of a diffuse infiltrative HCC type. * Fibrolamellar HCC, sarcomatoid HCC or mixed hepatocellular/ cholangiocarcinoma subtypes. * Clinically meaningful ascites. * Prior treatment with regorafenib, a PD-1, PD-L1/PD-L2, or cytotoxic T lymphocyte associated protein 4 (CTLA-4) inhibitors, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. * Major surgical procedure, open biopsy, or significant traumatic injury ≤28 days prior to randomization. * Active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. * Requirement of systemic treatment with either corticosteroids or other immunosuppressive medications ≤ 14 days prior to randomization. * Interstitial lung disease, non-infectious pneumonitis or uncontrolled lung diseases including pulmonary fibrosis, or clinically significant acute lung diseases. * Cardiovascular conditions as defined within the protocol. * Patient has a concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed ≤ 2 years before randomization. * Persistent proteinuria of NCI-CTCAE v5.0 Grade 3. * Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial.

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Conditions

The condition(s) this trial relates to.

hepatocellular carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carcinoma, hepatocellular

Contacts and locations

Locations

  • Antwerp University Hospital

    Edegem, 2650, Belgium

  • CHU Amiens-Picardie

    Amiens, 80054, France

  • Center of Oncology Euroclinic Victoria Hospital

    Iași, 700106, Romania

  • Cha Bundang Medical Center

    Seongnam-si, South Korea

  • Chang Gung Memorial Hospital - Linkou

    Taoyuan, 333, Taiwan

  • Clinic for Digestive Surgery, University Clinical Center of Serbia

    Belgrade, Serbia

  • Gazi University MF

    Ankara, 6560, Turkey (Türkiye)

  • Gülhane Eğitim ve Araştırma Hastanesi

    Ankara, 6010, Turkey (Türkiye)

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009, Spain

  • Humanity and Health Clinical Trial Center

    Hong Kong, 999077, Hong Kong

  • Hôpital Beaujon - APHP

    Clichy, 92110, France

  • Hôpital Henri Mondor

    Créteil, 94010, France

  • Inje University Haeundae Paik Hospital

    Busan, South Korea

  • Institue of Oncology Vojvodine Sremska Kamenica (Oncology Institute of Volvodina)

    Kamenitz, 21204, Serbia

  • Institutul Clinic Fundeni

    Bucharest, 22328, Romania

  • Israel-Georgian Medical Research Clinic Healthycore

    Tbilisi, 0112, Georgia

  • JSC VIANI Batumi Referral Hospital

    Batumi, 6010, Georgia

  • Koc University Hospital

    Istanbul, 34010, Turkey (Türkiye)

  • National Taiwan University Hospital

    Taipei, 10041, Taiwan

  • Ospedale Garibaldi Nesima

    Catania, 95122, Italy

  • Regional Institute of Gastroenterology and Hepatology "Dr Octavian Fodor"

    Cluj-Napoca, 400394, Romania

  • Severance Hospital, Yonsei University Health System

    Seoul, South Korea

  • UCL SAINT LUC - UC Louvain

    Brussels, 1200, Belgium

  • UCLA Santa Monica Hematology Oncology

    Santa Monica, California, 90404, United States

  • Universitätsmedizin: Medizinische Klinik und Poliklinik I

    Mainz, D-55131, Germany

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