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Liver cancer hope: new combo tested after standard treatment fails

NCT ID NCT04770896

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 26, 2026 · Updated 2 times

Summary

This study tests whether adding the immunotherapy drug atezolizumab to standard targeted therapy (lenvatinib or sorafenib) helps people with advanced liver cancer live longer. It includes about 557 adults whose cancer worsened after initial treatment with atezolizumab and bevacizumab. The goal is to see if the combination improves survival compared to targeted therapy alone.

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

557 people

The number who actually took part.

Started

Apr 2021

Expected to finish

Oct 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 patients. * Disease progression following prior atezolizumab plus bevacizumab combination treatment for HCC, for at least 4 consecutive treatment cycles, and 2 subsequent tumor assessments. It is required that at least 1 tumor assessment shows either stable disease (SD), partial response (PR), or complete response (CR). * At least one measurable (per RECIST v1.1) target lesion that has not been previously treated with local therapy or, if the target lesion is within the field of previous local therapy, has subsequently progressed in accordance with RECIST v1.1. * Eastern Cooperative Oncology Group Performance Status (ECOG PS) 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 Exclusion Criteria: * Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases. * History of leptomeningeal disease * History of hepatic encephalopathy, preceding 6 months, unresponsive to therapy within 3 days * Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC * 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

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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.

Unresectable hepatocellular carcinoma

Contacts and locations

Locations

  • A.O. S. Orsola Malpighi

    Bologna, Emilia-Romagna, 40138, Italy

  • A.O.U. Policlinico Paolo Giaccone

    Palermo, Sicily, 90127, Italy

  • APHM

    Marseille, 13385, France

  • APHP - Hopital Saint Antoine

    Paris, 75571, France

  • AZ Delta (Campus Rumbeke)

    Roeselare, 8800, Belgium

  • AZ KLINA

    Brasschaat, 2930, Belgium

  • Acibadem Altunizade Hastanesi

    Istanbul, Turkey (Türkiye)

  • Agioi Anargiroi Hospital of Kifissia

    Nea Kifissia, 14564, Greece

  • AirForce Specialized Hospital

    Cairo, 11391, Egypt

  • Anhui Province Cancer Hospital

    Hefei, 12345, China

  • Arthur J.E. Child Comprehensive Cancer Center-Calgary

    Calgary, Alberta, T2N 4N2, Canada

  • Azienda Osp Uni Seconda Università Degli Studi Di Napoli

    Naples, Campania, 80131, Italy

  • Azienda Ospedaliera Ordine Mauriziano di Torino

    Turin, Piedmont, 10128, Italy

  • Azienda Ospedaliera San Camillo Forlanini

    Rome, Lazio, 00152, Italy

  • Azienda Ospedaliero-Universitaria Careggi

    Florence, Tuscany, 50139, Italy

  • Azlenda Ospendaliero-Universitaria Pisana

    Pisa, Tuscany, 56100, Italy

  • Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji

    Bakirkoy / Istanbul, 34147, Turkey (Türkiye)

  • Beneficencia Portuguesa de Sao Paulo

    São Paulo, 01321-00, Brazil

  • CH Saint Eloi

    Montpellier, 34295, France

  • CHA Bundang Medical Center

    Gyeonggi-do, 13496, South Korea

  • CHRU de Lille - Hopital Claude Huriez

    Lille, 59037, France

  • CHU Bordeaux

    Pessac, 33604, France

  • CHU Grenoble Sud

    Grenoble, 38043, France

  • CHU de Nantes - Hotel Dieu

    Nantes, 44093, France

  • CHU de Toulouse - Hôpital Rangueil

    Toulouse, 31059, France

  • Cebu Doctors' University Hospital

    Cebu City, 6000, Philippines

  • Centre Eugene Marquis;Service d'oncologie

    Rennes, 35042, France

  • Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN

    Florianópolis, Santa Catarina, 88020-210, Brazil

  • Chi-Mei Medical Centre

    Tainan, 710, Taiwan

  • Christie Hospital Nhs Trust

    Manchester, M2O 4BX, United Kingdom

  • Chulalongkorn Hospital

    Bangkok, 10330, Thailand

  • Churchill Hospital

    Oxford, OX3 7LE, United Kingdom

  • Clinica CIMCA

    San José, 10103, Costa Rica

  • Clinica Universidad de Navarra Madrid

    Madrid, 28027, Spain

  • Clinica Universitaria de Navarra

    Pamplona/iruña, Navarre, 31008, Spain

  • Clinical Hospital Centre Zagreb

    Zagreb, 10000, Croatia

  • Clinicas Oncologicas Integradas - COI

    Rio de Janeiro, 22290-160, Brazil

  • Cliniques Universitaires St-Luc

    Brussels, 1200, Belgium

  • Complejo Hospitalario Universitario de Santiago (CHUS)

    Santiago de Compostela, LA Coruna, 15706, Spain

  • Complex Oncological Center - Plovdiv, EOOD

    Plovdiv, 4004, Bulgaria

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2, Canada

  • Ege Uni Medical Faculty Hospital

    Izmir, 35100, Turkey (Türkiye)

  • FSBI "National Medical Research Center of Oncology N.N. Blokhin?

    Moscow, Moscow Oblast, 115478, Russia

  • Faculty of Med. Siriraj Hosp.

    Bangkok, 10700, Thailand

  • Fondazione IRCCS Ospedale Maggiore Policlinico

    Milan, Lombardy, 20122, Italy

  • Fondazione Pascale

    Naples, Campania, 80100, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, Lazio, 00168, Italy

  • Freeman Hospital

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Fujian Provincial Hospital

    Fuzhou, 350001, China

  • Fujita Health University Hospital

    Aichi, 470-1192, Japan

  • Hacettepe Uni Medical Faculty Hospital

    Sihhiye/Ankara, 06230, Turkey (Türkiye)

  • Hammersmith Hospital

    London, W12 0HS, United Kingdom

  • Hiroshima University Hospital

    Hiroshima, 734-8551, Japan

  • Hopital Paul Brousse

    Villejuif, 94804, France

  • Hopitaux de Brabois - Gastro-Entereologie

    Vandœuvre-lès-Nancy, 54511, France

  • Hospital Erasme

    Brussels, 1070, Belgium

  • Hospital Felicio Rocho

    Belo Horizonte, Minas Gerais, 30110-160, Brazil

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007, Spain

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90035-000, Brazil

  • Hospital Sao Lucas - PUCRS

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

  • Hospital Son Llatzer

    Palma de Mallorca, Balearic Islands, 07198, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009, Spain

  • Hospital Universitario Reina Sofia

    Córdoba, 14004, Spain

  • Hospital Universitario la Fe

    Valencia, 46026, Spain

  • Hunan Cancer Hospital

    Changsha, 410013, China

  • I.M.Sechenov First Moscow State Medical University (1st MSMU)

    Moskva, Moscow Oblast, 119991, Russia

  • ICIMED Instituto de Investigación en Ciencias Médicas

    San José, 10108, Costa Rica

  • IRCCS Istituto Oncologico Veneto (IOV)

    Padova, Veneto, 35128, Italy

  • Inselspital Bern Medizin Gastroenterologie

    Bern, 3010, Switzerland

  • Institute Kanser Negara (IKN)

    Putrajaya, FED. Territory of Kuala Lumpur, 62250, Malaysia

  • Japanese Red Cross Musashino Hospital

    Tokyo, 180-8610, Japan

  • Japanese Red Cross Society Himeji Hospital

    Hyōgo, 670-8540, Japan

  • Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

    Nanjing, 210029, China

  • Jichi Medical University Hospital

    Tochigi, 329-0498, Japan

  • Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2, Canada

  • Kindai University Hospital

    Osaka, 589-8511, Japan

  • King College Hospital NHS Foundation Trust

    London, SE5 9RS, United Kingdom

  • Klinik Favoriten

    Vienna, 1100, Austria

  • Klinik Johann Wolfgang von Goethe Uni

    Frankfurt, 60590, Germany

  • Kurume University Hospital

    Fukuoka, 830-0011, Japan

  • Laiko General Hospital Athen

    Athens, 115 27, Greece

  • Makati Medical Center

    Makati City, 1229, Philippines

  • Med. Hochschule Hannover

    Hanover, 30625, Germany

  • Medipol Mega Üniversite Hastanesi Göztepe

    Bağcılar, 34214, Turkey (Türkiye)

  • Medizinische Universität Innsbruck

    Innsbruck, 6020, Austria

  • Memorial Ankara Hastanesi

    Ankara, 06520, Turkey (Türkiye)

  • Moscow City Oncology Hospital #62

    Moscow, Moscow Oblast, 125134, Russia

  • Multiprofile Hospital for Active Treatment Uni Hospital

    Panagyurishte, 4500, Bulgaria

  • 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 Taiwan University Hospital

    Zhongzheng Dist., 10048, Taiwan

  • North Estonia Medical Centre, Oncology and hematology Clinic

    Tallinn, 13419, Estonia

  • Ospedale del Mare

    Naples, Campania, 80147, Italy

  • Princess Margaret Cancer Center

    Toronto, Ontario, M5G 2M9, Canada

  • Queen Elizabeth Hospital

    Birmingham, B15 2TH, United Kingdom

  • Rabin Medical Center

    Petah Tikva, 4941492, Israel

  • Rambam Health Care Campus

    Haifa, 3109601, Israel

  • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, 200127, China

  • Royal Free Hospital

    London, NW3 2QS, United Kingdom

  • START Madrid. Centro Integral Oncologico Clara Campal

    Madrid, 28050, Spain

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • Shengjing Hospital of China Medical University

    Shenyang, 110004, China

  • Sourasky Medical Center

    Tel Aviv, 6423900, Israel

  • TAYS Radius rakennus

    Tampere, 33520, Finland

  • Tartu University Hospital

    Tartu, 50406, Estonia

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Liverpool, L7 8YA, United Kingdom

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, 510080, China

  • The Medical City

    Pasig, 1600, Philippines

  • The University of Osaka Hospital

    Osaka, 565-0871, Japan

  • Tianjin Cancer Hospital

    Tianjin, 300060, China

  • UZ Leuven

    Leuven, 3000, Belgium

  • Uludag Uni Hospital

    Bursa, 16059, Turkey (Türkiye)

  • Uni Malaya Medical Center

    Kuala Lumpur, FED. Territory of Kuala Lumpur, 59100, Malaysia

  • Uniklinik Mainz

    Mainz, 55131, Germany

  • Uniklinikum Salzburg, LKH

    Salzburg, 5020, Austria

  • University Medical Center Ljubljana

    Ljubljana, 1000, Slovenia

  • Universität Tübingen

    Tübingen, 72076, Germany

  • Universitätsklinikum St. Pölten

    Sankt Pölten, 3100, Austria

  • Universitätsklinikum Ulm

    Ulm, 89081, Germany

  • Universitätsspital Zürich Medizin Gastroenterologie

    Zurich, 8091, Switzerland

  • Yokohama City University Medical Center

    Kanagawa, 232-0024, Japan

  • Zhongshan Hospital Fudan University

    Shanghai, 200032, China

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