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

HCC Clinical Trial

— CHANCE023  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06024252
• Other study ID #: CHANCE023
• Status: Not yet recruiting
• Start date: September 1, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: August 2023
• Source: Zhongda Hospital
• Contact: Jian Lu, MD
• Phone: +86 5850654644
• Email: lujian43307131[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 1, 2024
• Est. primary completion date: December 1, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• HCC

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhongda Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Progression-Free Survival	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
Secondary	Objective response rate	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
Secondary	One-year survival rate	One-year survival rate: defined as the percentage of patients who are survival for 1 year from the start of this treatment.	1 year
Secondary	Immune-TACE PFS	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
Secondary	Disease control rate	Disease control rate (DCR): defined as the proportion of patients achieving complete response (CR) or partial response (PR) or stable disease (SD).	1 year
Secondary	Treatment pattern	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