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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Advanced Hepatocellular Carcinoma (HCC)

Intervention / Treatment
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* Procedure: DEB-TACE plus HAIC or HAIC alone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival (PFS) | 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 | Up to 3 year | 
| Overall Survival (OS) | 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 | Up to 3 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) | The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1 | Up to 3 year | 
| Duration of Response (DoR) | 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 | Up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HepaSphere, Transarterial chemoembolization, TACE, Hepatic Arterial Infusion Chemotherapy, HAIC