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Clinical Trials List

Protocol NumberWO41535
NCT Number(ClinicalTrials.gov Identfier)NCT04102098
Active

2019-11-01 - 2028-12-31

Phase III

Recruiting5

ICD-10D01.5

Carcinoma in situ of liver, gallbladder and bile ducts

ICD-9230.8

Carcinoma in situ of liver and biliary system

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

  • Trial Applicant

  • Sponsor

    Hoffmann-La Roche

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Yi-Hsiang Huang Digestive System Department
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shi-Ming Lin Digestive System Department
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 蘇維文 Digestive System Department
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ann-Lii Cheng Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ming-Lung Yu Digestive System Department
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or Ablation

Objectives

Primary Efficacy Objective(Primary Objective)  To evaluate the efficacy of atezolizumab plus bevacizumab compared with active surveillance Secondary Efficacy Objective  To evaluate the efficacy of atezolizumab plus bevacizumab compared with active surveillanceExploratory Efficacy Objective  To evaluate the efficacy of atezolizumab plus bevacizumab compared with active surveillanceSafety Objective  To evaluate the safety of atezolizumab plus bevacizumab compared with active surveillancePharmacokinetic Objective  To characterize the PK profile of atezolizumab when given in combination with bevacizumabImmunogenicity Objective  To evaluate the immune response to atezolizumabExploratory Immunogenicity Objective To evaluate potential effects of ADAsExploratory Biomarker Objective To identify and/or evaluate biomarkers that are predictive of response to study treatment(i.e., predictive biomarkers), are early surrogates of efficacy, are associated with progression to a more severe disease state(i.e., prognostic biomarkers), are associated with acquired resistance to study treatment, can provide evidence of studytreatment activity (i.e., pharmacodynamic biomarkers), or can increase the knowledge and understanding of diseasebiology and drug safety Exploratory Health Status Utility Objective  To evaluate health status utility scores of patients treated with atezolizumab plus bevacizumab compared with activesurveillance

Test Drug

Atezolizumab, Bevacizumab

Active Ingredient

Atezolizumab
Bevacizumab

Dosage Form

IVT
IVT

Dosage

1200mg/20ml
400mg/16ml

Endpoints

Primary Outcome Measures :
Recurrence-Free Survival (RFS), as Determined by IRF [ Time Frame: Baseline up to approximately 39 months ]
RFS is defined as the time from randomization to the first documented occurrence of intrahepatic or extrahepatic HCC as determined by an IRF, or death from any cause (whichever occurs first).

Secondary Outcome Measures :
Overall Survival (OS) [ Time Frame: Baseline up to approximately 91 months ]
OS is defined as the time from randomization to death from any cause.

RFS as Determined by the Investigator [ Time Frame: Baseline up to approximately 91 months ]
RFS is defined as the time from randomization to the first documented occurrence of intrahepatic or extrahepatic HCC as determined by an investigator, or death from any cause (whichever occurs first).

Time to Recurrence (TTR) [ Time Frame: Baseline up to approximately 91 months ]
TTR defined as the time from randomization to first documented occurrence of intrahepatic or extrahepatic HCC, as determined by the investigator and by an IRF.

RFS Rate at 24 and 36 Months, as Assessed by the IRF [ Time Frame: Randomization up to 24 months and up to 36 months ]
RFS Rate at 24 and 36 Months, as Assessed by the Investigator [ Time Frame: Randomization up to 24 months and up to 36 months ]
OS Rate at 24 and 36 Months [ Time Frame: Baseline to 24 and 36 months ]
OS rate defined as the proportion of patients who have not experienced death from any cause at 24 and 36 months after randomization.

Time to Extrahepatic Spread (EHS) or Macrovascular Invasion [ Time Frame: Baseline up to approximately 91 months ]
Time to EHS or macrovascular invasion after randomization, defined as the time from randomization to the first appearance of EHS or macrovascular invasion, as determined by the investigator.

RFS in Pd-L1-High Subgroup [ Time Frame: Baseline up to approximately 91 months ]
RFS after randomization as determined by the investigator and by an IRF, among patients in the PD-L1-high subgroup.

Percentage of Participants With Adverse Events [ Time Frame: Baseline up to approximately 91 months ]
Serum Concentration of Atezolizumab [ Time Frame: Prior to any drug administration on Day 1 of Cycles 1, 2, 3, 4, 8, 12, and 16 (each cycle is 21 days) ]
Number of Participants with Anti-Drug Antibodies (ADAs) to Atezolizumab [ Time Frame: Prior to any drug administration on Day 1 of Cycles 1, 2, 3, 4, 8, 12, and 16 (each cycle is 21 days) ]

Inclution Criteria

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 of 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

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

The Estimated Number of Participants

  • Taiwan

    40 participants

  • Global

    662 participants

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