A Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab
NCT ID: NCT04770896
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
557 participants
INTERVENTIONAL
2021-04-26
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Atezolizumab + Lenvatinib or Sorafenib
Participants will receive atezolizumab plus lenvatinib or sorafenib. Treatment will continue until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Atezolizumab
Atezolizumab will be administered by intravenous (IV) infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Lenvatinib
Lenvatinib will be administered once daily by mouth each day of every 21-day study treatment cycle. Participants with a baseline body weight of \< 60 kg will receive a daily dose of 8 mg. Participants with a baseline body weight of ≥ 60 kg will receive a daily dose of 12 mg.
Sorafenib
Sorafenib will be administered at a dose of 800 mg per day, i.e. two tablets of 200 mg swallowed by mouth twice daily (equivalent to a total daily dose of 800 mg) each day of every 21-day study treatment cycle.
Lenvatinib or Sorafenib
Participants will receive lenvatinib or sorafenib. Treatment will continue until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Lenvatinib
Lenvatinib will be administered once daily by mouth each day of every 21-day study treatment cycle. Participants with a baseline body weight of \< 60 kg will receive a daily dose of 8 mg. Participants with a baseline body weight of ≥ 60 kg will receive a daily dose of 12 mg.
Sorafenib
Sorafenib will be administered at a dose of 800 mg per day, i.e. two tablets of 200 mg swallowed by mouth twice daily (equivalent to a total daily dose of 800 mg) each day of every 21-day study treatment cycle.
Interventions
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Atezolizumab
Atezolizumab will be administered by intravenous (IV) infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Lenvatinib
Lenvatinib will be administered once daily by mouth each day of every 21-day study treatment cycle. Participants with a baseline body weight of \< 60 kg will receive a daily dose of 8 mg. Participants with a baseline body weight of ≥ 60 kg will receive a daily dose of 12 mg.
Sorafenib
Sorafenib will be administered at a dose of 800 mg per day, i.e. two tablets of 200 mg swallowed by mouth twice daily (equivalent to a total daily dose of 800 mg) each day of every 21-day study treatment cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Medizinische Universität Innsbruck
Innsbruck, , Austria
Uniklinikum Salzburg, LKH
Salzburg, , Austria
Universitätsklinikum St. Pölten
Sankt Pölten, , Austria
Klinik Favoriten
Vienna, , Austria
AZ KLINA
Brasschaat, , Belgium
Hospital Erasme
Brussels, , Belgium
Cliniques Universitaires St-Luc
Brussels, , Belgium
UZ Leuven
Leuven, , Belgium
AZ Delta (Campus Rumbeke)
Roeselare, , Belgium
Hospital Felicio Rocho
Belo Horizonte, Minas Gerais, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN
Florianópolis, Santa Catarina, Brazil
Clinicas Oncologicas Integradas - COI
Rio de Janeiro, , Brazil
Beneficencia Portuguesa de Sao Paulo
São Paulo, , Brazil
Multiprofile Hospital for Active Treatment Uni Hospital
Panagyurishte, , Bulgaria
Complex Oncological Center - Plovdiv, EOOD
Plovdiv, , Bulgaria
Arthur J.E. Child Comprehensive Cancer Center-Calgary
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
Juravinski Cancer Centre
Hamilton, Ontario, Canada
Princess Margaret Cancer Center
Toronto, Ontario, Canada
Hunan Cancer Hospital
Changsha, , China
Fujian Provincial Hospital
Fuzhou, , China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, , China
Nanfang Hospital, Southern Medical University
Guangzhou, , China
Anhui Province Cancer Hospital
Hefei, , China
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
Nanjing, , China
Zhongshan Hospital Fudan University
Shanghai, , China
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Shengjing Hospital of China Medical University
Shenyang, , China
Tianjin Cancer Hospital
Tianjin, , China
Clinica CIMCA
San José, , Costa Rica
ICIMED Instituto de Investigación en Ciencias Médicas
San José, , Costa Rica
Clinical Hospital Centre Zagreb
Zagreb, , Croatia
AirForce Specialized Hospital
Cairo, , Egypt
North Estonia Medical Centre, Oncology and hematology Clinic
Tallinn, , Estonia
Tartu University Hospital
Tartu, , Estonia
TAYS Radius rakennus
Tampere, , Finland
CHU Grenoble Sud
Grenoble, , France
CHRU de Lille - Hopital Claude Huriez
Lille, , France
APHM
Marseille, , France
CH Saint Eloi
Montpellier, , France
CHU de Nantes - Hotel Dieu
Nantes, , France
APHP - Hopital Saint Antoine
Paris, , France
CHU Bordeaux
Pessac, , France
Centre Eugene Marquis;Service d'oncologie
Rennes, , France
CHU de Toulouse - Hôpital Rangueil
Toulouse, , France
Hopitaux de Brabois - Gastro-Entereologie
Vandœuvre-lès-Nancy, , France
Hopital Paul Brousse
Villejuif, , France
Klinik Johann Wolfgang von Goethe Uni
Frankfurt, , Germany
Med. Hochschule Hannover
Hanover, , Germany
Uniklinik Mainz
Mainz, , Germany
Universität Tübingen
Tübingen, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Laiko General Hospital Athen
Athens, , Greece
Agioi Anargiroi Hospital of Kifissia
Nea Kifissia, , Greece
Rambam Health Care Campus
Haifa, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Sourasky Medical Center
Tel Aviv, , Israel
Fondazione Pascale
Napoli, Campania, Italy
Azienda Osp Uni Seconda Università Degli Studi Di Napoli
Napoli, Campania, Italy
Ospedale del Mare
Napoli, Campania, Italy
A.O. S. Orsola Malpighi
Bologna, Emilia-Romagna, Italy
Azienda Ospedaliera San Camillo Forlanini
Rome, Lazio, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, Italy
Fondazione IRCCS Ospedale Maggiore Policlinico
Milan, Lombardy, Italy
Azienda Ospedaliera Ordine Mauriziano di Torino
Turin, Piedmont, Italy
A.O.U. Policlinico Paolo Giaccone
Palermo, Sicily, Italy
Azienda Ospedaliero-Universitaria Careggi
Florence, Tuscany, Italy
Azlenda Ospendaliero-Universitaria Pisana
Pisa, Tuscany, Italy
IRCCS Istituto Oncologico Veneto (IOV)
Padua, Veneto, Italy
Fujita Health University Hospital
Aichi, , Japan
National Cancer Center Hospital East
Chiba, , Japan
Kurume University Hospital
Fukuoka, , Japan
Hiroshima University Hospital
Hiroshima, , Japan
Japanese Red Cross Society Himeji Hospital
Hyōgo, , Japan
Yokohama City University Medical Center
Kanagawa, , Japan
The University of Osaka Hospital
Osaka, , Japan
Kindai University Hospital
Osaka, , Japan
Jichi Medical University Hospital
Tochigi, , Japan
Japanese Red Cross Musashino Hospital
Tokyo, , Japan
Uni Malaya Medical Center
Kuala Lumpur, FED. Territory of Kuala Lumpur, Malaysia
Institute Kanser Negara (IKN)
Putrajaya, FED. Territory of Kuala Lumpur, Malaysia
Cebu Doctors' University Hospital
Cebu City, , Philippines
Makati Medical Center
Makati City, , Philippines
The Medical City
Pasig, , Philippines
FSBI "National Medical Research Center of Oncology N.N. Blokhin?
Moscow, Moscow Oblast, Russia
Moscow City Oncology Hospital #62
Moscow, Moscow Oblast, Russia
I.M.Sechenov First Moscow State Medical University (1st MSMU)
Moskva, Moscow Oblast, Russia
University Medical Center Ljubljana
Ljubljana, , Slovenia
National Cancer Center
Goyang-si, , South Korea
CHA Bundang Medical Center
Gyeonggi-do, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Son Llatzer
Palma de Mallorca, Balearic Islands, Spain
Complejo Hospitalario Universitario de Santiago (CHUS)
Santiago de Compostela, LA Coruna, Spain
Clinica Universitaria de Navarra
Pamplona/iruña, Navarre, Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Clinica Universidad de Navarra Madrid
Madrid, , Spain
START Madrid. Centro Integral Oncologico Clara Campal
Madrid, , Spain
Hospital Universitario la Fe
Valencia, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Inselspital Bern Medizin Gastroenterologie
Bern, , Switzerland
Universitätsspital Zürich Medizin Gastroenterologie
Zurich, , Switzerland
Chi-Mei Medical Centre
Tainan, , Taiwan
National Taiwan University Hospital
Zhongzheng Dist., , Taiwan
Chulalongkorn Hospital
Bangkok, , Thailand
Faculty of Med. Siriraj Hosp.
Bangkok, , Thailand
Memorial Ankara Hastanesi
Ankara, , Turkey (Türkiye)
Medipol Mega Üniversite Hastanesi Göztepe
Ba?c?lar, , Turkey (Türkiye)
Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
Bakirkoy / Istanbul, , Turkey (Türkiye)
Uludag Uni Hospital
Bursa, , Turkey (Türkiye)
Ac?badem Altunizade Hastanesi
Istanbul, , Turkey (Türkiye)
Ege Uni Medical Faculty Hospital
Izmir, , Turkey (Türkiye)
Hacettepe Uni Medical Faculty Hospital
Sihhiye/Ankara, , Turkey (Türkiye)
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, , United Kingdom
Royal Free Hospital
London, , United Kingdom
King College Hospital NHS Foundation Trust
London, , United Kingdom
Hammersmith Hospital
London, , United Kingdom
Christie Hospital Nhs Trust
Manchester, , United Kingdom
Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Churchill Hospital
Oxford, , United Kingdom
Countries
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Other Identifiers
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MO42541
Identifier Type: -
Identifier Source: org_study_id
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