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

Peking University Cancer Hospital & Institute

Status

Enrolling

Conditions

Advanced Hepatocellular Carcinoma (HCC)

Treatments

Procedure: DEB-TACE plus HAIC or HAIC alone

Study type

Observational

Funder types

Other

Identifiers

NCT05862181

HCC-HEPA-HAIC-001

Details and patient eligibility

About

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

Full 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

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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