A Study of Atezolizumab in Combination With Bevacizumab Compared With Sorafenib in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma

Completed · Phase 3

Conditions studied: Carcinoma, Hepatocellular

In brief

This study will evaluate the efficacy and safety of atezolizumab in combination with bevacizumab compared with sorafenib in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have received no prior systemic treatment.

Key facts

Study ID

NCT03434379

Run by

Hoffmann-La Roche

People needed

558

Starts

2018-03-15

Expected to finish

2022-11-17

Last updated by the study team

2023-10-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC)
• No prior systemic therapy for HCC. Previous use of herbal therapies/traditional Chinese medicines with anti-cancer activity included in the label is allowed, provided that these medications are discontinued prior to randomization.
• At least one measurable untreated lesion
• ECOG Performance Status of 0 or 1
• Adequate hematologic and end-organ function
• For women of childbearing potential: agreement to remain abstinent
• For men: agreement to remain abstinent
• Child-Pugh class A

You may not qualify if…

• History of leptomeningeal disease
• 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 scan
• Known active tuberculosis
• 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
• Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within at least 5 months after the last dose of atezolizumab, 6 months after the last dose of bevacizumab, or 1 month after the last dose of sorafenib
• Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
• Untreated or incompletely treated esophageal and/or gastric varices with bleeding or high-risk for bleeding
• A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment.
• Moderate or severe ascites
• History of hepatic encephalopathy
• Co-infection of HBV and HCV
• Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
• Uncontrolled tumor-related pain
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
• Uncontrolled or symptomatic hypercalcemia
• Treatment with systemic immunostimulatory agents
• Inadequately controlled arterial hypertension
• Prior history of hypertensive crisis or hypertensive encephalopathy
• Evidence of bleeding diathesis or significant coagulopathy
• History of intestinal obstruction and/or clinical signs or symptoms of GI obstruction including sub-occlusive disease related to the underlying disease or requirement for routine parenteral hydration
• Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture
• Metastatic disease that involves major airways or blood vessels, or centrally located mediastinal tumor masses
• Local therapy to liver within 28 days prior to initiation of study treatment or non-recovery from side effects of any such procedure
• Chronic daily treatment with a non-steroidal anti-inflammatory drug (NSAID)

Where it is running

• City of Hope — Duarte, California, United States
• Uni of California - San Diego; Cancer Center & Dept of Medicine — La Jolla, California, United States
• Kaiser Permanente Northern California — Novato, California, United States
• University of California Irvine Medical Center — Orange, California, United States
• Kaiser Permanente Sacramento Medical Center — Sacramento, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• Kaiser Permanente - San Francisco Medical Center — San Francisco, California, United States
• University of California Los Angeles — Santa Monica, California, United States
• Kaiser Permanente - Walnut Creek — Walnut Creek, California, United States
• Banner MD Anderson Cancer Center — Greeley, Colorado, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Washington University; Wash Uni. Sch. Of Med — St Louis, Missouri, United States
• University of New Mexico Comprehensive Cancer Center — Albuquerque, New Mexico, United States
• Laura and ISAAC Perlmutter Cancer Center at NYU Langone. — New York, New York, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• M.D Anderson Cancer Center; Uni of Texas At Houston — Houston, Texas, United States
• Swedish Cancer Inst. — Seattle, Washington, United States
• Bankstown-Lidcombe Hospital — Bankstown, New South Wales, Australia
• St George Hospital — Kogarah, New South Wales, Australia
• The Queen Elizabeth Hospital — Woodville, South Australia, Australia
• Sunshine Hospital — St Albans, Victoria, Australia
• St. Josephs Hospital and Medical Center — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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