A Study of Atezolizumab Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or Ablation
NCT ID: NCT04102098
Last Updated: 2025-12-11
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
668 participants
INTERVENTIONAL
2019-12-31
2027-07-16
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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Arm A (atezolizumab plus bevacizumab)
Participants will receive Atezolizumab + Bevacizumab until disease recurrence or unacceptable toxicity.
Atezolizumab
Atezolizumab 1200 mg will be administered by IV infusion on Day 1 of each 21-day cycle.
Bevacizumab
Bevacizumab will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle.
Arm B (active surveillance)
Active surveillance of participants.
No interventions assigned to this group
Interventions
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Atezolizumab
Atezolizumab 1200 mg will be administered by IV infusion on Day 1 of each 21-day cycle.
Bevacizumab
Bevacizumab will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Documented diagnosis of HCC that has been completely resected or ablated (RFA or MVA only)
* Absence of major macrovascular invasion (except Vp1/Vp2) and extrahepatic spread
* Absence of extrahepatic spread as confirmed by CT or MRI scan of the chest, abdomen, pelvis, and head prior to and following curative procedure
* Full recovery from surgical resection or ablation within 4 weeks prior to randomization
* High risk for HCC recurrence after resection or ablation
* For patients who received post-operative transarterial chemoembolization: full recovery from the procedure within 4 weeks prior to randomization
* For patients with resected HCC, availability of a representative baseline tumor tissue sample
* ECOG Performance Status of 0 or 1
* Child-Pugh Class A status
* Adequate hematologic and end-organ function
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods
* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm
Exclusion Criteria
* Evidence of residual, recurrent, or metastatic disease at randomization
* Clinically significant ascites
* History of hepatic encephalopathy
* Prior bleeding event due to untreated or incompletely treated esophageal and/or gastric varices within 6 months prior to randomization
* Have received more than 1 cycle of adjuvant TACE following surgical resection
* 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 CT scan
* Significant cardiovascular disease within 3 months prior to Day 1 of Cycle 1, unstable arrhythmia, or unstable angina
* 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
* Active tuberculosis
* Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
* Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of atezolizumab or within 6 months after the final dose of bevacizumab. Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to Day 1 of Cycle 1.
* Co-infection with HBV and HCV
* Co-infection with HBV and hepatitis D viral infection
* Clinical significant uncontrolled or symptomatic hypercalcemia
* Any treatment for HCC prior to resection or ablation, including systemic therapy and locoregional therapy such as TACE
* Treatment with systemic immunostimulatory or immunosuppressive agents
* Inadequately controlled arterial hypertension
* History of hypertensive crisis or hypertensive encephalopathy
* Significant vascular disease
* Evidence of bleeding diathesis or significant coagulopathy
* Current or recent use of aspirin or full-dose oral or parenteral anticoagulants
* Core biopsy within 3 days of Day 1 of Cycle 1
* History of GI fistula, GI perforation, or intra-abdominal abscess
* Serious non-healing or dehiscing wound
* Major surgical procedure within four weeks
* Chronic daily treatment with a non-steroidal anti-inflammatory drug
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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Kaiser Permanente Los Angeles
Los Angeles, California, United States
Mercy Medical Center
Baltimore, Maryland, United States
Henry Ford Health System
Detroit, Michigan, United States
Columbia University Medical Center
New York, New York, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
The University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Swedish Cancer Inst.
Seattle, Washington, United States
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Lkh-Univ. Klinikum Graz
Graz, , Austria
Klinikum Klagenfurt am Wörtersee
Klagenfurt, , Austria
Medizinische Universität Wien
Vienna, , Austria
Imeldaziekenhuis
Bonheiden, , Belgium
AZ Delta (Campus Rumbeke)
Roeselare, , Belgium
Hospital Sao Rafael - HSR
Salvador, Estado de Bahia, Brazil
Sociedade beneficente de senhoras Hospital Sirio Libanes
Brasília, Federal District, Brazil
Hospital do Cancer UOPECCAN
Cascavel, Paraná, Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, São Paulo, Brazil
Gordon & Leslie Diamond Health Care Centre
Vancouver, British Columbia, Canada
McGill University Health Centre - Glen Site
Montreal, Quebec, Canada
Anhui Provincial Hospital
Anhui, , China
Beijing Cancer Hospital
Beijing, , China
Peking Union Medical College Hospital
Beijing, , China
Affiliated Hospital of Bengbu Medical College
Bengbu, , China
The First Hospital of Jilin University
Changchun, , China
West China Hospital, Sichuan University
Chengdu, , China
Daping Hospital of Third Military Medical University
Chongqing, , China
The Second Affiliated Hospital of Dalian Medical University
Dalian, , China
Fujian Cancer Hospital
Fuzhou, , China
Mengchao Hepatobiliary Hospital Of Fujian Medical University
Fuzhou, , China
Cancer Center of Guangzhou Medical University
Guangzhou, , China
Sun Yet-sen University Cancer Center
Guangzhou, , China
Zhujiang Hospital, Southern Medical University
Guangzhou, , China
Nanfang Hospital, Southern Medical University
Guangzhou, , China
Zhejiang Cancer Hospital
Hangzhou, , China
Harbin Medical University Cancer Hospital
Harbin, , China
Anhui Province Cancer Hospital
Hefei, , China
The Second Affiliated Hospital of Anhui Medical University
Hefei, , China
Shandong Cancer Hospital
Jinan, , China
The 81st Hospital of P.L.A.
Nanjing, , China
Zhongda Hospital Affiliated to Southeast University
Nanjing, , China
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Nanjing, , China
Guangxi Cancer Hospital of Guangxi Medical University
Nanning, , China
The First Affiliate Hospital of Guangxi Medical University
Nanning, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
Huashan Hospital Affiliated to Fudan University
Shanghai, , China
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Zhongshan Hospital Fudan Unvierstiy
Shanghai, , China
The First Affiliated Hospital of China Medical University
Shenyang, , China
Shengjing Hospital of China Medical University
Shenyang, , China
Tianjin Cancer Hospital
Tianjin, , China
The Tumor Hospital of Xinjiang Medical University
Ürümqi, , China
Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology
Wuhan, , China
Renmin Hospital of Wuhan University
Wuhan, , China
Zhongnan Hospital of Wuhan University
Wuhan, , China
Northern Jangsu People's Hospital
Yangzhou, , China
Clinica CIMCA
San José, , Costa Rica
Fakultni nemocnice Brno
Brno, , Czechia
Fakultni Thomayerova Nemocnice
Prague, , Czechia
Hopital Jean Minoz
Besançon, , France
Hôpital Avicenne - Groupement Hospitalier Universitaire Paris Seine St Denis
Bobigny, , France
Hôpital Albert Michallon
La Tronche, , France
Fondation Hopital Saint Joseph
Marseille, , France
CHU Bordeaux - Hôpital Haut-Lévêque
Pessac, , France
Hopital Robert Debre
Reims, , France
Hopital de Pontchaillou
Rennes, , France
CHU de Toulouse - Hôpital Rangueil
Toulouse, , France
Hopitaux de Brabois - Gastro-Entereologie
Vandœuvre-lès-Nancy, , France
Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I.
Bonn, , Germany
Klinik Johann Wolfgang von Goethe Uni
Frankfurt am Main, , Germany
Klinikum der Uni Regensburg
Regensburg, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Queen Mary Hospital
Hong Kong, , Hong Kong
Prince of Wales Hospital
Shatin, , Hong Kong
Ospedale Regionale Di Parma
Parma, Emilia-Romagna, Italy
Ospedale Maggiore Policlinico
Milan, Lombardy, Italy
Asst Santi Paolo E Carlo
Milan, Lombardy, Italy
Azlenda Ospendaliero-Universitaria Pisana
Pisa, Tuscany, Italy
Chiba University Hospital
Chiba, , Japan
Ehime Prefectural Central Hospital
Ehime, , Japan
Hiroshima University Hospital
Hiroshima, , Japan
Sapporo Kosei General Hospital
Hokkaido, , Japan
Hyogo Medical University Hospital
Hyōgo, , Japan
Japanese Red Cross Society Himeji Hospital
Hyōgo, , Japan
Kanazawa University Hospital
Ishikawa, , Japan
Yokohama City University Medical Center
Kanagawa, , Japan
Kanagawa Cancer Center
Kanagawa, , Japan
Kitasato University Hospital
Kanagawa, , Japan
Kumamoto University Hospital
Kumamoto, , Japan
Osaka Red Cross Hospital
Osaka, , Japan
Kindai University Hospital
Osaka, , Japan
Tokushima University Hospital
Tokushima, , Japan
Toranomon Hospital
Tokyo, , Japan
The University of Tokyo Hospital
Tokyo, , Japan
Japanese Red Cross Musashino Hospital
Tokyo, , Japan
Filios Alta Medicina
Monterrey, Nuevo León, Mexico
Oaxaca Site Management Organization
Oaxaca City, , Mexico
Maastricht University Medical Center
Maastricht, , Netherlands
Auckland City Hospital
Auckland, , New Zealand
Instituto Nacional de Enfermedades Neoplasicas
Lima, , Peru
Clínica San Gabriel
Lima, , Peru
Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie
Warsaw, , Poland
First Moscow State Medical University n.a. I.M. Sechenov
Moscow, Moscow Oblast, Russia
Group of companies "Medci"
Moskva, Moscow Oblast, Russia
Clinical hospital #1, FBHI Volga district medical center, Federal Medical and Biological Agency
Nizhny Novgorod, Niznij Novgorod, Russia
Russian Scientific Center of Radiology and Surgical Technologies
Pesochny, Sankt-Peterburg, Russia
National Cancer Centre
Singapore, , Singapore
Tan Tock Seng Hospital
Singapore, , Singapore
Pusan National University Hospital
Busan, , South Korea
Kyungpook National University Hospital
Daegu, , South Korea
CHA Bundang Medical Center
Gyeonggi-do, , South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, , South Korea
Ajou University Medical Center
Gyeonggi-do, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Seoul St Mary's Hospital
Seoul, , South Korea
Boramae Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Ulsan University Hosiptal
Ulsan, , South Korea
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
Hospital Universitario Infanta Cristina
Badajoz, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Changhua Christian Hospital
Chang-hua, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
National Taiwan Uni Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation - Linkou
Taoyuan District, , Taiwan
Rajavithi Hospital
Bangkok, , Thailand
Siriraj Hospital
Bangkok, , Thailand
Chiang Rai Prachanukroh Hospital
Chiang Rai, , Thailand
Chulabhorn Hospital
Lak Si, , Thailand
Adana Baskent University Hospital
Adana, , Turkey (Türkiye)
Countries
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References
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Qin S, Chen M, Cheng AL, Kaseb AO, Kudo M, Lee HC, Yopp AC, Zhou J, Wang L, Wen X, Heo J, Tak WY, Nakamura S, Numata K, Uguen T, Hsiehchen D, Cha E, Hack SP, Lian Q, Ma N, Spahn JH, Wang Y, Wu C, Chow PKH; IMbrave050 investigators. Atezolizumab plus bevacizumab versus active surveillance in patients with resected or ablated high-risk hepatocellular carcinoma (IMbrave050): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2023 Nov 18;402(10415):1835-1847. doi: 10.1016/S0140-6736(23)01796-8. Epub 2023 Oct 20.
Hack SP, Spahn J, Chen M, Cheng AL, Kaseb A, Kudo M, Lee HC, Yopp A, Chow P, Qin S. IMbrave 050: a Phase III trial of atezolizumab plus bevacizumab in high-risk hepatocellular carcinoma after curative resection or ablation. Future Oncol. 2020 May;16(15):975-989. doi: 10.2217/fon-2020-0162. Epub 2020 Apr 30.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2019-002491-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-504303-86-00
Identifier Type: CTIS
Identifier Source: secondary_id
WO41535
Identifier Type: -
Identifier Source: org_study_id
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