Efficacy, Safety, and Treatment Patterns of Transcatheter Arterial Chemoembolization (TACE) Combined With Atezolizumab and Bevacizumab in Unresectable Hepatocellular Carcinoma: a Multicenter, Retrospective, Observational Real-world Study

NCT06024252 | Unknown

• 1 other identifier: CHANCE023
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate the efficacy and safety of TACE combined with atezolizumab + bevacizumab in the treatment of unresectable hepatocellular carcinoma, and the treatment patterns of the combination regimen

Conditions

HCC

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Overall survival (OS): defined as the time from the start of the first TACE or atezolizumab + bevacizumab (whichever occurs first) to death due to any cause.

  1 year

Secondary Outcomes (6)

• Progression-Free Survival

  1 year

• Objective response rate

  1 year

• One-year survival rate

  1 year

• Immune-TACE PFS

  1 year

• Disease control rate

  1 year

Interventions

TACE DRUG

TACE in combination with atezolizumab + bevacizumab for at least one interval of no more than eight weeks.

Also known as: Atezolizumab, Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The target population for the planned retrospective analysis of this project is patients who have been diagnosed with unresectable HCC according to the guidelines for Diagnosis and Treatment of Primary Liver Cancer in China (2019 Edition) and treated with TACE combined with atezolizumab + bevacizumab.

You may qualify if:

• All patients were diagnosed with unresectable hepatocellular carcinoma according to the guidelines for Diagnosis and Treatment of Primary Liver Cancer in China (2019 Edition);
• Patients ≥ 18 years old, male or female;
• Child-Pugh Class A and B liver function;
• ECOG-PS score of 0 \~ 2 points;
• Received TACE in combination with atezolizumab + bevacizumab for at least one interval of no more than eight weeks.

You may not qualify if:

• Other primary malignancies;
• Incomplete data, such as no baseline image that can be assessed according to RECIST 1.1 or mRECIST, and survival outcome.

Sponsors & Collaborators

• Zhongda Hospital: lead

MeSH Terms

Interventions

atezolizumab; Bevacizumab

Intervention Hierarchy (Ancestors)

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

Study Officials

• Gao-Jun Teng, MD

  Zhongda Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Lu, MD

CONTACT

+86 5850654644; lujian43307131@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Gao-Jun Teng

Study Record Dates

• First Submitted: August 6, 2023
• First Posted: September 6, 2023
• Study Start: September 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: September 6, 2023

Record last verified: 2023-08