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New immunotherapy combo shows promise for advanced liver cancer

NCT ID NCT05883644

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 This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Updated 2 times

Summary

This study tests a combination of two immunotherapy drugs (durvalumab and tremelimumab) as a first treatment for people with advanced liver cancer that cannot be removed by surgery. About 111 participants will receive the drugs to see how safe they are and whether they shrink tumors. The goal is to control the disease and improve survival, not to cure it.

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

111 people

The number who actually took part.

Started

Jun 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 130 years

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: * Confirmed unresectable HCC based on histopathological findings (prior histological verification confirming HCC is acceptable), or radiological findings in participants with cirrhosis where histopathological confirmation is not clinically feasible * Must not have received prior systemic therapy for HCC * Participants expected to live 12 weeks or more * At least 1 measurable lesion, not previously irradiated, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter with CT or MRI, and that is suitable for accurate repeated measurements as per RECIST 1.1 guidelines * Must not be eligible for LRT for unresectable HCC. * Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy LRT) or stage C * Child-Pugh Score classification on liver disease and WHO/ECOG PS at enrolment complying one of the following: 1. Child-Pugh score B7 or B8 with a WHO/ECOG PS of 0-1 at enrolment, without main trunk portal vein thrombosis. 2. Child-Pugh class A with a WHO/ECOG PS of 2 at enrolment, without main trunk portal vein thrombosis (ie, ECOG PS 2 participants with main portal vein tumour thrombosis are excluded from this study). 3. Child-Pugh class A with WHO/ECOG PS of 0-1 at enrolment and with chronic main trunk portal vein thrombosis * Participants with hepatitis B virus (HBV) infection must be treated with antiviral therapy prior to enrolment. * Participants with hepatitis C virus (HCV) infection must have confirmed diagnosis of HCV characterized by the presence of detectable HCV RNA or anti-HCV upon enrolment * Adequate organ and bone marrow function * Negative pregnancy test (serum) for women of childbearing potential. * Female participants must be 1 year post-menopausal, surgically sterile, or using one highly effective form of birth control * Male and Female participants and their partners must use an acceptable method of contraception. * Body weight \>30 kg Exclusion Criteria: * Any evidence of acute or uncontrolled diseases, chronic diverticulitis or previous complicated diverticulitis, or history of allogeneic organ transplant, which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardise compliance with the protocol * Refractory nausea and vomiting, chronic gastrointestinal (GI) disease, inability to swallow a formulated product, or previous significant bowel resection * History of symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia * History of another primary malignancy except for: 1. Malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence, or 2. Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or lentigo maligna that has undergone potentially curative therapy, or 3. Adequately treated carcinoma in situ without evidence of disease * Persistent toxicities (Common Terminology Criteria for Adverse Events \[CTCAE\] Grade \> 1) caused by previous anticancer therapy * Active or prior documented autoimmune or inflammatory disorders, autoimmune pneumonitis, and autoimmune myocarditis * History of active primary immunodeficiency * History of leptomeningeal carcinomatosis * History of hepatic encephalopathy within the past 6 months or requirement for medications to prevent or control encephalopathy * Active or prior documented GI bleeding (eg. esophageal varices or ulcer bleeding) within the past 6 months. * Clinical judgement of acute main trunk portal vein thrombosis * History of previous, or current, brain metastases or spinal cord compression * Known fibrolamellar hepatocellular carcinoma (HCC), sarcomatoid HCC, or mixed cholangiocarcinoma and HCC * Clinically meaningful ascites * Participants co-infected with HBV and HCV or co-infected with HBV and hepatitis D virus (HDV) * Known to have tested positive for human immunodeficiency virus (HIV) or active tuberculosis infection * Any concomitant medication known to be associated with Torsades de Pointes * Prior exposure to immune-mediated therapy excluding therapeutic anticancer vaccines * Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab or tremelimumab * Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention" and "Major surgical procedure (as defined by the investigator) or significant traumatic injury within 4 weeks of the first dose of study intervention.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Research Site

    La Jolla, California, 92093, United States

  • Research Site

    Shreveport, Louisiana, 71103, United States

  • Research Site

    Detroit, Michigan, 48202, United States

  • Research Site

    Bobigny, 93000, France

  • Research Site

    Clichy, 92110, France

  • Research Site

    Créteil, 94010, France

  • Research Site

    Marseille, 13005, France

  • Research Site

    Rennes, 35000, France

  • Research Site

    Berlin, D-13353, Germany

  • Research Site

    Cologne, 50937, Germany

  • Research Site

    Frankfurt, 60488, Germany

  • Research Site

    Lübeck, 23538, Germany

  • Research Site

    Hong Kong, 0000, Hong Kong

  • Research Site

    Hong Kong, 999077, Hong Kong

  • Research Site

    Milan, 20132, Italy

  • Research Site

    Naples, 80147, Italy

  • Research Site

    Padova, 35128, Italy

  • Research Site

    Pisa, 56126, Italy

  • Research Site

    Rozzano, 20089, Italy

  • Research Site

    Turin, 10128, Italy

  • Research Site

    Kanazawa, 920-8641, Japan

  • Research Site

    Kashiwa, 277-8577, Japan

  • Research Site

    Matsuyama, 790-0024, Japan

  • Research Site

    Musashino-shi, 180-8610, Japan

  • Research Site

    Osakasayama-shi, 589-8511, Japan

  • Research Site

    Yokohama, 241-8515, Japan

  • Research Site

    Singapore, 119228, Singapore

  • Research Site

    Singapore, 169610, Singapore

  • Research Site

    Singapore, 308433, Singapore

  • Research Site

    Gyeonggi-do, 13620, South Korea

  • Research Site

    Seongnam-si, 13496, South Korea

  • Research Site

    Seoul, 03722, South Korea

  • Research Site

    Seoul, 05505, South Korea

  • Research Site

    Seoul, 06351, South Korea

  • Research Site

    Barcelona, 8035, Spain

  • Research Site

    Córdoba, 14004, Spain

  • Research Site

    Madrid, 28007, Spain

  • Research Site

    Madrid, 28040, Spain

  • Research Site

    Pamplona, 31008, Spain

  • Research Site

    Hanoi, 100000, Vietnam

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