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
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Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | 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
