Ate-Bev Early Response Prediction Model in Advanced HCC

May 12, 2025 updated by: Jeong-Hoon Lee, Seoul National University Hospital

Developing Atezolizumab-Bevacizumab Treatment Response Early Prediction Model in Advanced Hepatocellular Carcinoma Patients

The prognosis of hepatocellular carcinoma is poor compared to other carcinomas. Many drugs have recently been developed, and recently, atezolizumab-bevacizumab treatment was superior to sorafenib, the conventional treatment for advanced hepatocellular carcinoma. However, there is no information on the evaluation on the evaluation of treatment response for atezolizumab-bevacizumab combination therapy compared to atezolizumab alone or bevacizumab alone. Therefore, this study aimed to create a predictive model that can detect treatment response at an early stage.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

170

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jeong-Hoon Lee, MD PhD
  • Phone Number: +82-2-2072-2228
  • Email: pindra@empal.com

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients who were diagnosed with advanced hepatocellular carcinoma and who were scheduled to receive atezolizumab-bevacizumab as the first-line therapy in a single tertiary hospital are included.

Description

Inclusion Criteria:

  • Patients who were diagnosed with advanced hepatocellular carcinoma and who were scheduled to receive atezolizumab-bevacizumab as the first-line therapy
  • Patients willing to participate in this study

Exclusion Criteria:

  • Individuals with a history of severe contrast allergy
  • Individuals with severe comorbidities (according to the American Society of Clinical Oncology-Friends of Cancer Research Organ Dysfunction.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ate-Bev
Individuals diagnosed with advanced hepatocellular carcinoma and treated with atezolizumab-bevacizumab between the ages of 18-80 were included. According to the recommendations of the American Society of Clinical Oncology-Friends of Cancer Research Organ Dysfunction, patients with comorbidities were excluded.
Diagnostic test: Early response evaluation
Atezolizumab and bevacizumab are administered every three weeks, and before to the second treatment cycle, blood tests and imaging tests are conducted (week 5). This precedes the standard response evaluation (week 9-12).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression free survival
Time Frame: the follow up will be continued until June 22th 2025.
the index date is the date of treatment with atezolizumab and bevacizumab, and the event is either death or tumor progression of the tumor.
the follow up will be continued until June 22th 2025.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: the follow up will be continued until June 22th 2025.
the index date is the date of treatment with atezolizumab and bevacizumab, and the event is death.
the follow up will be continued until June 22th 2025.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2022

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 28, 2023

First Submitted That Met QC Criteria

February 28, 2023

First Posted (Actual)

March 10, 2023

Study Record Updates

Last Update Posted (Actual)

May 15, 2025

Last Update Submitted That Met QC Criteria

May 12, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2206-066-1332

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe