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NCT04102098

PHASE3

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This study will evaluate the efficacy and safety of adjuvant therapy with atezolizumab plus bevacizumab compared with active surveillance in participants with completely resected or ablated hepatocellular carcinoma (HCC) who are at high risk for disease recurrence.

Official title: A Phase III, Multicenter, Randomized, Open-Label Study of Atezolizumab (Anti-PD-L1 Antibody) Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or Ablation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

668

Start Date

2019-12-31

Completion Date

2026-05-15

Last Updated

2026-06-18

Healthy Volunteers

Conditions

Carcinoma, Hepatocellular

Interventions

DRUG

Atezolizumab

Atezolizumab 1200 mg will be administered by IV infusion on Day 1 of each 21-day cycle.

DRUG

Bevacizumab

Bevacizumab will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle.

Inclusion Criteria: * Participants with a first diagnosis of HCC who have undergone either a curative resection or ablation (radiofrequency ablation \[RFA\] or microwave ablation \[MVA\] only) within 4-12 weeks prior to randomization * 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: * Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC * 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

Locations (134)

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

And 34 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (134)