Clinical trial NCT05862181: The Comparison Between HepaSphere Drug-eluting Bead Transarterial Chemoembolization Combined With Hepatic Arterial Infusion Chemotherapy in Advanced Hepatocellular Carcinoma
Official title: Efficacy and Safety of HepaSphere Drug-eluting Bead Transarterial Chemoembolization Combined With Hepatic Arterial Infusion Chemotherapy in Advanced Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Advanced Hepatocellular Carcinoma (HCC)
Keywords: HepaSphere
Transarterial chemoembolization
TACE
Hepatic Arterial Infusion Chemotherapy
HAIC
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all of patients were diagnosed as HCC. Some of them may received the treatment before enrollment. They only received HepaSphere plus HAIC or HAIC alone as the interventional therapy during this study.

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

Eligibility criteria: 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

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Up to 3 year
measure: Overall Survival (OS)
timeFrame: Up to 3 year
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to 3 year
measure: Duration of Response (DoR)
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
References: