Atezolizumab Plus Bevacizumab With HCC and HBV Infection

NCT04180072 | Active Not Recruiting DMC

• 1 other identifier: T2219
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 7

Brief Summary

This is a single-arm clinical trial. The main objective is to determine the efficacy of atezolizumab+bevacizumab therapy in patients with advanced hepatocellular carcinoma and with chronic hepatitis B virus infection. All eligible patients will receive atezolizumab + bevacizumab therapy.

Conditions

Carcinoma, Hepatocellular

Keywords

Carcinoma, Hepatocellular

Outcome Measures

Primary Outcomes (1)

• Best overall response rate

  Complete or partial response, as determined by the investigator according to RECIST v1.1

  The last patient in has been treated for 6 months. All patients who have a PR or CR before that are responders

Secondary Outcomes (10)

• Proportion of subjects with ≥ grade 3 liver-related adverse events (AE)

  12 weeks after the first drug administration.

• Incidence and severity of total AE, liver related AE, and liver immune-related AE

  30 days after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurs first

• HBV reactivation

  Baseline up to approximately 2.5years.

• HBV-related hepatitis flare

  Every 4 weeks for 6 months in permanent discontinuation of study drug treatment

• Progression-free survival

  The time from registration to the first occurrence of disease progression or death from any cause (whichever occurs first assessed up to 100 months)

Study Arms (1)

Atezolizumab plus bevacizumab

EXPERIMENTAL

Atezolizumab 1200 mg IV plus bevacizumab 15 mg/kg IV on day 1 every 3 weeks. Study treatment will continue until documented tumor progression or occurrence of unacceptable toxicity.

Drug: Atezolizumab; Drug: Bevacizumab

Interventions

Atezolizumab DRUG

Atezolizumab 1200 mg IV on day 1 every 3 weeks

Also known as: Tecentriq

Atezolizumab plus bevacizumab

Bevacizumab DRUG

Bevacizumab 15 mg/kg IV on day 1 every 3 weeks

Also known as: Avastin

Atezolizumab plus bevacizumab

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 20 years, according to local regulation in Taiwan, at time of signing Informed Consent Form.
• Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology.
• Agreement to receive a mandatory tumor biopsy for enrollment into this study.
• Disease that is not amenable to curative surgical and/or locoregional therapies, or progressive disease after surgical and /or locoregional therapies.
• No prior systemic therapy (including systemic investigational agents) for HCC.
• Documented chronic HBV infection, defined by positive serum surface antigen (HBsAg), and HBV DNA \> 2000 IU/mL obtained within 28 days prior to initiation of study treatment.
• Agreement to receive anti-HBV treatment (per local standard of care; e.g., entecavir)
• to 2 weeks prior to study entry and willingness to continue treatment for the length of the study.
• At least one measurable (per RECIST 1.1) lesion. Patients who received prior local therapy (e.g., radiofrequency ablation or transarterial chemoembolization, etc.) are eligible provided the target lesion(s) have not been previously treated with local therapy or the target lesion(s) within the field of local therapy have subsequently progressed in accordance with RECIST version 1.1.
• ECOG Performance Status of 0 or 1 within 7 days prior to registration.
• Child-Pugh class A (see Appendix) within 14 days prior to registration
• Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 7 days prior to registration, unless otherwise specified:
• ANC ≥ 1.5 x 109/L (1500/μL) without granulocyte colony-stimulating factor support; platelet count ≥ 75 x 109/L (75,000/μL) without transfusion; and hemoglobin ≥ 90 g/L (9 g/dL)(patients may be transfused to meet this criterion).
• Liver transaminases (AST and ALT) ≤ 5 x upper limit of normal (ULN)
• Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula)

You may not qualify if:

• Histological diagnosis of fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
• Imaging finding for HCC corresponding to any of the following:
• o Clear invasion into the bile duct
• Co-infection of HBV and HCV. Patients with a history of HCV infection but who are negative for HCV RNA by PCR will be considered non-infected with HCV.
• Known human immunodeficiency virus (HIV) infection.
• History of esophageal/gastric varices or active peptic ulcers that are considered to have high risk of bleeding.
• History of upper gastrointestinal bleeding within 1 year.
• Major systemic diseases that the investigator considers inappropriate for participation.
• History of severe allergic anaphylactic reactions to antibodies or fusion proteins
• Prior allogeneic stem cell or solid organ transplantation.
• Treatment with investigational therapy within 28 days prior to initiation of study treatment.
• Prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody (or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways).
• Local therapy to liver (e.g., radiofrequency ablation, transarterial chemoembolization, etc.) within 28 days prior to initiation of study treatment or non-recovery from side effects of any such procedure.
• Radiotherapy within 28 days and abdominal/ pelvic radiotherapy within 60 days prior to initiation of study treatment, except for palliative radiotherapy to bone lesions.
• Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to enrollment. Patients should be recovered from the effects of radiation. There is no required minimum recovery period.

Sponsors & Collaborators

• China Medical University Hospital: collaborator
• National Health Research Institutes, Taiwan: lead
• National Taiwan University Hospital: collaborator
• Taipei Veterans General Hospital, Taiwan: collaborator
• Mackay Memorial Hospital: collaborator
• Changhua Christian Hospital: collaborator
• National Cheng-Kung University Hospital: collaborator
• Kaohsiung Medical University Chung-Ho Memorial Hospital: collaborator
• Taichung Veterans General Hospital: collaborator

Study Sites (7)

Chang Gung Memorial Hospital

Linkou District, Taiwan

Location

China Medical University Hospital

Taichung, Taiwan

Location

Taichung Veterans General Hospital

Taichung, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

Mackay Memorial Hospital

Taipei, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

atezolizumab; Bevacizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Chiun Hsu, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2019
• First Posted: November 27, 2019
• Study Start: March 12, 2020
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (7)