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New immunotherapy cocktail aims to fight untreatable liver cancer

NCT ID NCT05904886

Disease control Sponsor: Hoffmann-La Roche 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This phase 3 trial is testing whether adding tiragolumab to the standard combination of atezolizumab and bevacizumab helps people with advanced liver cancer that cannot be surgically removed. About 687 participants will receive either the three-drug combo or the two-drug combo plus a placebo. The study measures how long the cancer stays under control and overall survival, but the tiragolumab arm was recommended to stop early, so results should be interpreted cautiously.

What this could mean

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

Active substance
tiragolumab (an immunotherapy drug) combined with atezolizumab and bevacizumab
What this could lead to
If successful, this combination could offer a new first-line treatment option for people with advanced liver cancer, potentially improving how long they live and delaying cancer growth.
What could go wrong
This is an early-stage analysis of a large trial; the tiragolumab arm was recommended to stop early due to a sponsor memo, raising questions about benefit. Side effects from immunotherapy can be serious, and the added benefit of tiragolumab is not yet proven.

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

687 people

The number who actually took part.

Started

Sep 2023

Expected to finish

Sep 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 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: * Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/cytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic participants * Disease that is not amenable to curative surgical and/or locoregional therapies * No prior systemic treatment for locally advanced or metastatic and/or unresectable HCC-measurable disease according to RECIST v1.1 * Eastern cooperative oncology group (ECOG) performance status of 0 or 1 within 7 days prior to randomization * Child-pugh Class A within 7 days prior to randomization * Adequate hematologic and end-organ function * Female participants of childbearing potential must be willing to avoid pregnancy within 5 months after the final dose of atezolizumab, within 6 months after the final dose of bevacizumab, and within 90 days after the final dose of tiragolumab/placebo * Male participants with a female partner of childbearing potential or pregnant female partner must remain abstinent or use a condom during the treatment period and for 6 months after the final dose of bevacizumab and for 90 days after the final dose of tiragolumab/placebo to avoid exposing the embryo. Exclusion Criteria: * Pregnancy or breastfeeding within 5 months after the final dose of atezolizumab, within 6 months after the final dose of bevacizumab, and within 90 days after the final dose of tiragolumab/placebo * Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies * Treatment with investigational therapy within 28 days prior to initiation of study treatment * Treatment with locoregional therapy to liver within 28 days prior to initiation of study treatment, or non-recovery from side effects of any such procedure * Treatment with systemic immunostimulatory agents * Treatment with systemic immunosuppressive medication * Untreated or incompletely treated esophageal and/or gastric varices with bleeding or that are at high risk for bleeding * A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment * Active or history of autoimmune disease or immune deficiency * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan * History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death * Mixed histology or other subtypes/variants of HCC, including, but not limited to, known liver adenocarcinoma, fibrolamellar HCC, sarcomatoid HCC, other rare HCC variant, or mixed cholangiocarcinoma and HCC * Co-infection with hepatitis B virus (HBV) and hepatitis C virus (HCV) * Acute epstein-barr virus (EBV) infection or known or suspected chronic active EBV infection * Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.

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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.

Hepatocellular carcinoma

Contacts and locations

Locations

  • ?zmir Medical Point

    Kar?iyaka, 35575, Turkey (Türkiye)

  • A.O. S. Orsola Malpighi

    Bologna, Emilia-Romagna, 40138, Italy

  • A.O.U. Policlinico Paolo Giaccone

    Palermo, Sicily, 90127, Italy

  • A.O.U.I. Verona-Ospedale Policlinico G.B. Rossi Borgo Roma

    Verona, Veneto, 37134, Italy

  • APHP - Hopital Saint Antoine

    Paris, 75571, France

  • AZ Delta (Campus Rumbeke)

    Roeselare, 8800, Belgium

  • Adana Baskent University Medical Faculty

    Adana, 01220, Turkey (Türkiye)

  • Anhui Provincial Hospital

    Hefei, 230001, China

  • Ankara Bilkent City Hospital

    Ankara, 06490, Turkey (Türkiye)

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Auckland City Hospital

    Auckland, 1023, New Zealand

  • Az. Osp. G. Panico

    Tricase, Apulia, Italy

  • Az. Osp. Uni Ria San Martino

    Genoa, Liguria, 16132, Italy

  • Baoji Central Hospital

    Baoji, 721008, China

  • Beijing Cancer Hospital

    Beijing, 100142, China

  • CEDOES - Diagnóstico e Pesquisa

    Vitória, Espírito Santo, 29055-450, Brazil

  • CHA Bundang Medical Center

    Gyeonggi-do, 13496, South Korea

  • CHRU de Lille - Hopital Claude Huriez

    Lille, 59037, France

  • CHU CAEN - Hôpital de la Côte de Nacre

    Caen, 14033, France

  • Cancer & Hematology Centers of Western Michigan

    Grand Rapids, Michigan, 49503, United States

  • Centre Hospitalier Valence

    Valence, 26953, France

  • Centre National d'Oncologie Médicale et de Radiothérapie Alassane Ouattara (CNRAO)

    Abidjan, Côte d’Ivoire

  • Centro Medico Nacional Siglo Xxi - Imss

    Mexico City, Mexico CITY (federal District), 06720, Mexico

  • Centro de Investigacion Clinica de Oaxaca

    Oaxaca City, Oaxaca, 68020, Mexico

  • Chang Gung Medical Foundation - Linkou

    Taoyuan, 333, Taiwan

  • Charlotte Maxeke Johannesburg Academic Hospital

    Johannesburg, 2193, South Africa

  • Chi-Mei Medical Centre

    Tainan, 710, Taiwan

  • Chiba University Hospital

    Chiba, 260-8677, Japan

  • China Medical University Hospital

    Taichung, 404, Taiwan

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128, South Korea

  • Christchurch Hospital

    Christchurch, 8011, New Zealand

  • Chulalongkorn Hospital

    Bangkok, 10330, Thailand

  • City of Hope Cancer Center

    Duarte, California, 91010, United States

  • Clinica Universitaria de Navarra

    Pamplona/iruña, Navarre, 31008, Spain

  • Clinica Universitaria de Navarra de Madrid;Servicio de Hepatologia

    Madrid, 28027, Spain

  • Clinicas Oncologicas Integradas - COI

    Rio de Janeiro, 22290-160, Brazil

  • Cliniques Universitaires St-Luc

    Brussels, 1200, Belgium

  • Columbia University

    New York, New York, 10032-3725, United States

  • Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico

    Jaén, 23007, Spain

  • Ehime Prefectural Central Hospital

    Ehime, 790-0024, Japan

  • First Affiliated Hospital of Medical College of Xi'an Jiaotong University

    Xi'an, 710061, China

  • Florida Cancer Specialist, North Region

    St. Petersburg, Florida, 33705, United States

  • Florida Cancer Specialists - Fort Myers (Broadway)

    Fort Myers, Florida, 33901, United States

  • Fondation Hopital Saint Joseph

    Marseille, 13285, France

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, Lazio, 00168, Italy

  • Fujita Health University Hospital

    Aichi, 470-1192, Japan

  • Gazi Uni Medical Faculty Hospital

    Ankara, 06500, Turkey (Türkiye)

  • Genesis Cancer Center

    Hot Springs, Arkansas, 71913, United States

  • Hammersmith Hospital

    London, W12 0HS, United Kingdom

  • Harbin Medical University Cancer Hospital

    Harbin, 150081, China

  • Hartford Healthcare Cancer Institute at Hartford Hospital

    Hartford, Connecticut, 06106, United States

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Hiroshima University Hospital

    Hiroshima, 734-8551, Japan

  • Hokkaido University Hospital

    Hokkaido, 060-8648, Japan

  • Hopital Dupuytren

    Limoges, 87042, France

  • Hopital Hotel Dieu Et Hme

    Nantes, 44093, France

  • Hopital Paul Brousse

    Villejuif, 94804, France

  • Hopital Robert Debre

    Reims, 51092, France

  • Hopitaux de Brabois - Gastro-Entereologie

    Vandœuvre-lès-Nancy, 54511, France

  • Hospital Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital Clinico de Valencia

    Valencia, 46010, Spain

  • Hospital Duran i Reynals

    Barcelona, 08907, Spain

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007, Spain

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011, Spain

  • Hospital Universitario Puerta de Hierro

    Madrid, 28222, Spain

  • Hospital de Cancer de Barretos

    Barretos, São Paulo, 14784-400, Brazil

  • Hospital de Navarra

    Navarra, Navarre, 31008, Spain

  • Hospital do Cancer de Pernambuco - HCP

    Recife, Pernambuco, 50040-000, Brazil

  • Hunan Cancer Hospital

    Changsha, 410013, China

  • ID Clinic

    Mysłowice, 41-400, Poland

  • IRCCS Istituto Clinico Humanitas

    Rozzano, Lombardy, 20089, Italy

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Instituto Nacional de Ciencias Médicas Y de Nutricion Salvador Zubirán

    Mexico City, Mexico CITY (federal District), 14000, Mexico

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo, São Paulo, 01246-000, Brazil

  • Iwate Medical University Hospital

    Numakunai, 028-3695, Japan

  • James J Peters VA Hospital / Mental Illness Research Education and Clinic Center

    The Bronx, New York, 10468, United States

  • Japanese Red Cross Musashino Hospital

    Tokyo, 180-8610, Japan

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2, Canada

  • Jichi Medical University Hospital

    Tochigi, 329-0498, Japan

  • Jos University Teaching Hospital

    Jos, 930232, Nigeria

  • Juravinski Hospital

    Hamilton, Ontario, L8V 1C3, Canada

  • KBTH

    Accra, 0000, Ghana

  • Kanagawa Cancer Center

    Kanagawa, 241-8515, Japan

  • Kanazawa University Hospital

    Ishikawa, 920-8641, Japan

  • Kelsey Seybold Clnic

    Houston, Texas, 77005, United States

  • Khon Kaen Uni

    Khon Kaen, 40002, Thailand

  • Kindai University Hospital

    Osaka, 589-8511, Japan

  • Kitasato University Hospital

    Kanagawa, 252-0375, Japan

  • Klinikum Esslingen

    Esslingen am Neckar, 73730, Germany

  • Kurume University Hospital

    Fukuoka, 830-0011, Japan

  • Kyoto University Hospital

    Kyoto, 606-8507, Japan

  • Lagos University Teaching Hospital Lagos (LUTH), Lagos State

    Lagos, Nigeria

  • Limpopo Cancer Research Institute

    Polokwane, 0700, South Africa

  • Lishui Central Hospital

    Lishui, 323000, China

  • Maharaj Nakorn Chiang Mai Hospital

    Chiang Mai, 50200, Thailand

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905, United States

  • McGill University Health Centre - Glen Site

    Montreal, Quebec, H4A 3J1, Canada

  • MedStar Washington Hosp Center

    Washington D.C., District of Columbia, 20010, United States

  • Mengchao Hepatobiliary Hospital Of Fujian Medical University

    Fuzhou, 350025, China

  • Mercy Medical Center

    Baltimore, Maryland, 21202, United States

  • Miami VA Healthcare System

    Miami, Florida, 33125, United States

  • Minnesota Oncology Hematology Woodbury

    Woodbury, Minnesota, 55125, United States

  • Montefiore Medical Center

    The Bronx, New York, 10461, United States

  • NIO im Marii Sklodowskiej-Curie

    Warsaw, 02-034, Poland

  • NYU Langone

    New York, New York, 10016, United States

  • Nanfang Hospital, Southern Medical University

    Guangzhou, 510515, China

  • National Cancer Center

    Goyang-si, 10408, South Korea

  • National Cancer Center Hospital East

    Chiba, 277-8577, Japan

  • National Cancer Centre

    Singapore, 168583, Singapore

  • National Cheng Kung University Hospital

    Tainan, 00704, Taiwan

  • National Taiwan Uni Hospital

    Taipei, 100, Taiwan

  • North Texas VA Medical Center

    Dallas, Texas, 75216, United States

  • Norton Cancer Institute - Audubon

    Louisville, Kentucky, 40217, United States

  • Ochsner Cancer Inst.

    New Orleans, Louisiana, 70121, United States

  • OncoMed

    Mexico City, Mexico CITY (federal District), 03100, Mexico

  • Oncoclínicas do Brasil - BELO HORIZONTE

    Belo Horizonte, Minas Gerais, 30170-080, Brazil

  • PanOncology Trials

    San Juan, 00935, Puerto Rico

  • Peoples Hospital of Hunan Province

    Changsha, 410007, China

  • Polyclinique Internationale Sainte Anne- Marie (PISAM)

    Abidjan, BP 1463 Abidjan, Côte d’Ivoire

  • Prince of Wales Hosp

    Shatin, Hong Kong

  • Queen Mary Hospital

    Hong Kong, Hong Kong

  • Ramathibodi Hospital

    Bangkok, 10400, Thailand

  • Renji Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, 200127, China

  • Royal Free Hospital

    London, NW3 2QG, United Kingdom

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

  • Sapporo Kosei General Hospital

    Hokkaido, 060-0033, Japan

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 003-722, South Korea

  • Shengjing Hospital of China Medical University

    Shenyang, 110004, China

  • Stanford Cancer Center

    Palo Alto, California, 94304, United States

  • Sun yat-sen University Cancer Center

    Guangzhou, China

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5, Canada

  • Sweden Ghana Medical Center

    Accra, Ghana

  • Swedish Cancer Inst.

    Seattle, Washington, 98104, United States

  • The First Affiliated Hospital of College of Medicine, Zhejiang University

    Hangzhou, 310003, China

  • The First Hospital of Jilin University

    Changchun, 130021, China

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, 230601, China

  • The University of Osaka Hospital

    Osaka, 565-0871, Japan

  • Thomas Jefferson Uni

    Philadelphia, Pennsylvania, 19107, United States

  • Tianjin Cancer Hospital

    Tianjin, 300060, China

  • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430030, China

  • Toranomon Branch Hospital

    Kanagawa, 213-8587, Japan

  • Toranomon Hospital

    Tokyo, 105-8470, Japan

  • Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

    Edirne, 22030, Turkey (Türkiye)

  • UCLA Cancer Center

    Santa Monica, California, 90404, United States

  • UCSF Fresno at Community Cancer Institute

    Clovis, California, 93611, United States

  • UZ Antwerpen

    Edegem, 2650, Belgium

  • Uganda Cancer Institute

    Kampala, Uganda

  • Ulsan University Hosiptal

    Ulsan, 44033, South Korea

  • Uniklinik Mainz

    Mainz, 55131, Germany

  • Univ of Wisconsin-Madison

    Madison, Wisconsin, 53792, United States

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, 602-8566, Japan

  • University of California San Diego Moores Cancer Center

    La Jolla, California, 92037, United States

  • University of Illinois

    Chicago, Illinois, 60612, United States

  • University of Nairobi - Institute of Tropical and Infectious Diseases

    Nairobi, Kenya

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514, United States

  • University of Southern California

    Los Angeles, California, 90033, United States

  • Universität Tübingen

    Tübingen, 72076, Germany

  • Universitätsklinikum Magdeburg Klinik für Gastroenterologie und Hepatologie

    Magdeburg, 39120, Germany

  • Va Palo Alto Health Care System

    Palo Alto, California, 94304, United States

  • Virginia Mason Medical Center

    Seattle, Washington, 98101, United States

  • Washington Uni School of Medicine

    St Louis, Missouri, 63110, United States

  • Wellington Hospital

    Wellington, 6021, New Zealand

  • West China Hospital - Sichuan University

    Chengdu, 610047, China

  • Western General Hospital

    Edinburgh, EH4 2XU, United Kingdom

  • Xi'an Inernational Medical Center Hospital

    Xi'an, 710119, China

  • Zhejiang Provincial People?s Hospital

    Hangzhou, 310014, China

  • Zhongshan Hospital Fudan Unvierstiy

    Shanghai, 200032, China

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