Efficacy and Safety of TACE in Combination With ICIs for HCC: a Real-world Study

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Other: TACE+ICIs; Procedure: TACE

• Registration Number: NCT04975932
• Lead Sponsor: Zhongda Hospital

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) in patients with hepatocellular carcinoma (HCC) .

Detailed Description

Transarterial chemoembolization (TACE) can induce immunogenic cell death and tumor-specific immune response which results in the release of tumor antigens and transform "cold" tumors with lacking immune effector cells into "hot" tumors with immune effector cells infiltration. This provides a theoretical basis for TACE combined with immune checkpoint inhibitors (ICIs) in hepatocellular carcinoma (HCC) patients. The purpose of this study is to evaluate the safety and efficacy of TACE in combination with ICIs in patients with HCC. This real-world study also explores the optimal combined treatment and outcome of HCC patients for providing further information for clinical practice and trials.

Study Timeline

• Study Start: 2021-07-01
• Study First Submitted: 2021-07-02
• Study First Submitted QC: 2021-07-22
• Study First Posted: 2021-07-26
• Primary Completion: 2022-05-31
• Study Completion: 2023-02-08
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-12
• Last Update Posted: 2023-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 826

Inclusion Criteria

1. diagnosed with HCC by radiology, histology, or cytology;
2. patients who underwent TACE combined with ICIs therapies ( with or without molecular targeted therapies) were included in the study group. For patients in the study group, ICIs therapies were received before the TACE or within 2 months after TACE and at least one cycle of immunotherapy has been received;
3. during the same period, patients who underwent TACE without the combination of ICIs therapies ( with or without molecular targeted therapies) were included into the control group;
4. patients who underwent TACE combined with ICIs therapies and molecular targeted therapies, molecular targeted therapies must be performed simultaneously with TACE or immunotherapy.

Exclusion Criteria

1. exceeding the time interval of the combination therapy defined above;
2. missing follow-up data;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group: TACE+ICIs	TACE+ICIs	TACE: cTACE (conventional TACE) or dTACE (drug-eluting beads TACE); ICIs: atezolizumab, pembrolizumab, nivolumab, camrelizumab, tislelizumab, sintilimab or other ICIs
Control group: TACE	TACE	TACE: cTACE (conventional TACE) or dTACE (drug-eluting beads TACE);

Primary Outcome Measures

Name	Time	Method
Progression free survival(PFS)	up to approximately 1 years	The PFS is defined as the time from the initiation of any combination treatment to progression according to mRECIST or death from any cause. When pseudoprogression is suspected by investigator, tumor response will be re-assessed per iRECIST to confirm (also applicable for secondary endpoint of efficacy).

Secondary Outcome Measures

Name	Time	Method
Adverse event(AE)	baseline to end of study (approximately 2 years)	Number and degree of the AEs according to CTCAE version 5.0.
Overall survival(OS)	up to approximately 2 years	The OS is defined as the time from the initiation of any combination treatment to death from any cause.
Time to Progression(TTP)	up to approximately 1 years	The TTP is defined as the time from the initiation of any combination treatment to progression according to mRECIST. When pseudoprogression is suspected by investigator, tumor response will be re-assessed per iRECIST to confirm.
Objective response rate(ORR)	6-8 week after TACE	The ORR is defined as the proportion of patients with a documented complete response or partial response per mRECIST.
Disease control rate(DCR)	6-8 week after TACE	The DCR is defined as the proportion of patients with a documented complete response, partial response, or stable disease according to mRECIST.

Trial Locations

Locations (1)

Gao-Jun Teng; 🇨🇳 Nanjing, China