Organ-specific Responses to Atezolizumab Plus Bevacizumab in Advanced HCC

NCT04862949 | Completed Results

• 1 other identifier: 2021-04-010-001
• Study Type: observational
• Target: 131
• Locations: 1 country
• Sites: 1

Brief Summary

Hepatocellular carcinoma (HCC) is one of the most frequent causes of cancer-related deaths globally and in Korea. Many patients diagnosed at advanced stage, and systemic therapy is mainstay of treatment in patients with advanced HCC. However, immune-checkpoint inhibitor (ICI) monotherapy did not significantly improve overall survival in phase III studies. According to previous retrospective analyses, ICI treatment in advanced HCC showed different organ-specific responses. The intrahepatic HCC was the least responsive organ to ICI treatment. The failure of phase III trials of ICI monotherapy may have been attributed to different organ-specific response pattern of ICIs. Combination of atezolizumab plus bevacizumab is expected to overcome the immunosuppressive microenvironment of liver and may enhance intrahepatic response of ICI.

Conditions

Advanced Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma, atezolizumab, bevacizumab

Outcome Measures

Primary Outcomes (1)

• Percentage of Lesions With Organ-specific Response

  Organ-specific response will be assessed at the lesion level according to RECIST 1.1 criteria. Up to two target lesions per organ (maximum of five total lesions per patient) will be selected and measured unidimensionally. Complete response (CR) is defined as disappearance of the lesion or lymph node short axis diameter \<1.0 cm. Partial response (PR) is defined as ≥30% reduction in lesion size. Progressive disease (PD) is defined as ≥20% increase in lesion size. Stable disease (SD) is defined as neither CR, PR, nor PD. New lesions are recorded in addition to original target lesions to determine the total tumor burden.

  From treatment initiation until last follow-up (median 10.1 months)

Study Arms (1)

Atezolizumab plus bevacizumab

Patients received combination therapy with atezolizumab and bevacizumab as first-line systemic treatment for advanced HCC.

Drug: Atezolizumab plus bevacizumab

Interventions

Atezolizumab plus bevacizumab DRUG

Patients received combination therapy with atezolizumab (Tecentriq) and bevacizumab (Avastin) as first-line systemic treatment for advanced hepatocellular carcinoma.

Also known as: Atezolizumab, Bevacizumab

Atezolizumab plus bevacizumab

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients enrollment was performed in the CHA Bundang Medical Center, Ulsan University Hospital and Chinese University of Hong Kong

You may qualify if:

• Confirmed HCC pathological or non-invasive assessment according to American Association for the Study of Liver Diseases (AASLD) criteria
• ECOG performance status 0 or 1
• Patients who received Atezolizumab and Bevacizumab combination therapy as first-line systemic treatment for unresectable HCC
• Barcelona Clinic Liver Cancer (BCLC) stage B or C
• Child-Pugh class A
• Measurable lesion
• Adequate hematologic and organ function

You may not qualify if:

• History of autoimmune disease
• Concomitant anticoagulation at therapeutic doses. Low dose aspirin for
• cardio protection is permitted.

Sponsors & Collaborators

• CHA University: lead
• Hoffmann-La Roche: collaborator

Study Sites (1)

Cha Medical Center

Seongnam-si, Gyeonggi-do, 13496, South Korea

Location

Related Publications (24)

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Related Links

• Lee M, Ryoo BY, Hsu CH, et al: Randomised efficacy and safety results for atezolizumab (Atezo) + bevacizumab (Bev) in patients (pts) with previously untreated, unresectable hepatocellular carcinoma (HCC). Annals of Oncology 30:v875, 2019
• T. Yau, J.W. Park, R.S. Finn, et al: LBA38\_PR - CheckMate 459: A randomized, multi-center phase III study of nivolumab (NIVO) vs sorafenib (SOR) as first-line (1L) treatment in patients (pts) with advanced hepatocellular carcinoma (aHCC).

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

Results Point of Contact

• Title: Hong Jae Chon
• Organization: CHA Bundang Medical Center

minidoctor@cha.ac.kr

82-31-780-3928

Study Officials

• Hong Jae Chon, MD, PhD

  CHA University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: April 28, 2021
• Study Start: May 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: March 9, 2023
• Last Updated: December 12, 2025
• Results First Posted: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)