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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-12-31

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

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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

Conditions

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Advanced Hepatocellular Carcinoma (HCC)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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HEPA-HAIC group

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

DEB-TACE plus HAIC or HAIC alone

Intervention Type PROCEDURE

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

DEB-TACE plus HAIC or HAIC alone

Intervention Type PROCEDURE

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

Interventions

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DEB-TACE plus HAIC or HAIC alone

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

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No