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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)

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ClinicalTrials.gov Identifier: NCT06024252
Recruitment Status : Not yet recruiting
First Posted : September 6, 2023
Last Update Posted : September 6, 2023
Sponsor:
Information provided by (Responsible Party):
Gao-jun Teng, Zhongda Hospital

Study Description
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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

Condition or disease Intervention/treatment
HCC Drug: TACE

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 Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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
Estimated Study Start Date : September 1, 2023
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : June 1, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Drug: TACE
    TACE in combination with atezolizumab + bevacizumab for at least one interval of no more than eight weeks.
    Other Names:
    • Atezolizumab
    • Bevacizumab

Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06024252


Contacts
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Contact: Jian Lu, MD +86 5850654644 lujian43307131@126.com

Sponsors and Collaborators
Zhongda Hospital
Investigators
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Principal Investigator: Gao-Jun Teng, MD Zhongda Hospital
More Information
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Responsible Party: Gao-jun Teng, Dr. Gao-Jun Teng, Zhongda Hospital
ClinicalTrials.gov Identifier: NCT06024252    
Other Study ID Numbers: CHANCE023
First Posted: September 6, 2023    Key Record Dates
Last Update Posted: September 6, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Digestive System Diseases
Liver Diseases
Atezolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action