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 (CHANCE023)

August 29, 2023 updated by: Gao-jun Teng, Zhongda Hospital
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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a multi-center, retrospective and observational real-world study to explore the efficacy, safety and treatment pattern of TACE combined with Atezolizumab + Bevacizumab in unresectable hepatocellular carcinoma. 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 1 year
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression-Free Survival
Time Frame: 1 year
Progression-Free Survival (PFS): defined as the time from the start of the first TACE or atezolizumab + bevacizumab (whichever occurs first) to the first occurrence of disease progression or death from any cause.
1 year
Objective response rate
Time Frame: 1 year
Objective response rate (ORR): defined as the percentage of patients with objective response (CR and PR) from the start of treatment until tumor progression.
1 year
One-year survival rate
Time Frame: 1 year
One-year survival rate: defined as the percentage of patients who are survival for 1 year from the start of this treatment.
1 year
Immune-TACE PFS
Time Frame: 1 year

Immune-TACE PFS: defined as the time from the first TACE or atezolizumab bevacizumab (whichever occurs first) to the occurrence of one of the following events (whichever occurs first):

  • 20% enlargement of intra- or extra-hepatic lesions as assessed by mRECIST or appearance of new extra-hepatic lesions;
  • TACE refractoriness: insufficient tumor response in the treated tumor for three consecutive times (20% increase by mRECIST);
  • Deterioration of macrovascular invasion (MVI, defined as tumor invasion of the portal vein or hepatic vein and its branches);
  • Deterioration of liver function to Child-Pugh C or mALBI 2b;
  • Death from any cause.
1 year
Disease control rate
Time Frame: 1 year
Disease control rate (DCR): defined as the proportion of patients achieving complete response (CR) or partial response (PR) or stable disease (SD).
1 year
Treatment pattern
Time Frame: 1 year
Treatment pattern: including the timing and frequency of TACE (including its matching chemotherapy regimen), the treatment regimen of atezolizumab + bevacizumab, the sequence of combination therapy and the treatment regimen of the latter line.
1 year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhongda Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gao-Jun Teng, MD, Zhongda 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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 6, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHANCE023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

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