The Comparison Between HepaSphere Drug-eluting Bead Transarterial Chemoembolization Combined With Hepatic Arterial Infusion Chemotherapy in Advanced Hepatocellular Carcinoma

Sponsor

Peking University Cancer Hospital & Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT05862181

Collaborator

(none)

200

Enrollment

Location

Anticipated Duration (Months)

18.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Transarterial chemoembolization (TACE) is widely applied and shows good efficacy in advanced hepatocellular carcinoma (HCC). Recently, hepatic arterial infusion chemotherapy (HAIC) has also gained popularity in the treatment of HCC. Several studies have described the comparison between HAIC and TACE or TACE combined with HAIC. However, the evaluation between TACE plus HAIC and HAIC is rarely reported. Here, we will evaluate the performance of HepaSphere DEB-TACE combined with HAIC (HEPA-HAIC) comparing to HAIC in patients with advanced HCC

Condition or Disease	Intervention/Treatment	Phase
Advanced Hepatocellular Carcinoma (HCC)	Procedure: DEB-TACE plus HAIC or HAIC alone

Detailed Description

This is a double-arm, retrospective, observational study. The patients diagnosed as advanced HCC and treated with HepaSphere plus HAIC or single HAIC in the interventional therapy department of Peking University Cancer Hospital & Institute from May 2018 to May 2022. These patients are grouped into two cohorts. One is HEPA-HAIC group, the other is HAIC group. To access the effect of HepaSphere plus HAIC and single HAIC on the treatment of advanced HCC, the treatment efficacy and safety will be analyzed between these two cohorts. To avoid the selection bias, Propensity score matching (PSM) will be also conducted. The primary endpoints are progression-free survival (PFS) and overall survival (OS); the secondary endpoint includes objective response rate (ORR), disease control rate (DCR) and safety

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Efficacy and Safety of HepaSphere Drug-eluting Bead Transarterial Chemoembolization Combined With Hepatic Arterial Infusion Chemotherapy in Advanced Hepatocellular Carcinoma

Actual Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
HEPA-HAIC group HEPA-HAIC group is composed of advanced HCC patients treated with HepaSphere DEB-TACE combined with HAIC as the interventional therapy	Procedure: DEB-TACE plus HAIC or HAIC alone the patients received DEB-TACE plus HAIC or HAIC at least twice during this observational study
HAIC group HAIC group is composed of advanced HCC patients treated with only HAIC as the interventional therapy	Procedure: DEB-TACE plus HAIC or HAIC alone the patients received DEB-TACE plus HAIC or HAIC at least twice during this observational study

Arm

Intervention/Treatment

HEPA-HAIC group

HEPA-HAIC group is composed of advanced HCC patients treated with HepaSphere DEB-TACE combined with HAIC as the interventional therapy

Procedure: DEB-TACE plus HAIC or HAIC alone

the patients received DEB-TACE plus HAIC or HAIC at least twice during this observational study

HAIC group

HAIC group is composed of advanced HCC patients treated with only HAIC as the interventional therapy

Procedure: DEB-TACE plus HAIC or HAIC alone

the patients received DEB-TACE plus HAIC or HAIC at least twice during this observational study

Outcome Measures

Primary Outcome Measures

Progression-Free Survival (PFS) [Up to 3 year]
Progression-free survival is defined as the time from the start of treatment DEB-TACE plus HAIC or HAIC until the first documentation of disease progression or death due to any cause, whichever occurs first
Overall Survival (OS) [Up to 3 year]
Overall survival is defined as the time from the start of treatment with DEB-TACE plus HAIC or HAIC until death due to any cause

Secondary Outcome Measures

Objective Response Rate (ORR) [Up to 3 year]
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1
Duration of Response (DoR) [Up to 3 years]
Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age: ≥18 years old
Gender: no limitation
Diagnosed as primary hepatocellular carcinoma histologically or clinically
Imaging data within 31 days at enrollment and at least one measurable lesion (according to mRECIST criteria) is available
Patients only received treatment with HepaSphere combined with hepatocellular arterial infusion chemotherapy (HAIC) or HAIC alone during the observation period
Child-Pugh: A-B
ECOG: 0-2.

Exclusion Criteria:

Other cancer diseases are co-existed
Drug-eluting beads from other manufacturers were used during DEB-TACE
DEB-TACE combined with HAIC or HAIC alone was used as postoperative adjuvant therapy
Pre- or post-surgery relevant examination results were unavailable
Imaging information for effectiveness evaluation was unavailable
Follow-up failure due to patient information errors, loss, refusal, etc