Efficacy and Safety of HepaSphere Drug-eluting Bead Transarterial Chemoembolization Combined With Hepatic Arterial Infusion Chemotherapy in Advanced Hepatocellular Carcinoma
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Advanced Hepatocellular Carcinoma (HCC)
- Sponsor
- Peking University Cancer Hospital & Institute
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Progression-Free Survival (PFS)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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
Investigators
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
Outcomes
Primary Outcomes
Progression-Free Survival (PFS)
Time Frame: 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)
Time Frame: 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 Outcomes
- Duration of Response (DoR)(Up to 3 years)
- Objective Response Rate (ORR)(Up to 3 year)