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

Recruiting

• Conditions: Advanced Hepatocellular Carcinoma (HCC)
• Interventions: Procedure: DEB-TACE plus HAIC or HAIC alone

• Registration Number: NCT05862181
• Lead Sponsor: Peking University Cancer Hospital & Institute

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

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 Timeline

• Study Start: 2023-01-01
• Status Verified: 2023-03
• Study First Submitted: 2023-05-08
• Study First Submitted QC: 2023-05-08
• Study First Posted: 2023-05-17
• Last Update Submitted: 2023-05-19
• Last Update Posted: 2023-05-22
• Primary Completion: 2023-07
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HEPA-HAIC group	DEB-TACE plus HAIC or HAIC alone	HEPA-HAIC group is composed of advanced HCC patients treated with HepaSphere DEB-TACE combined with HAIC as the interventional therapy
HAIC group	DEB-TACE plus HAIC or HAIC alone	HAIC group is composed of advanced HCC patients treated with only HAIC as the interventional therapy

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China