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

Advanced Hepatocellular Carcinoma (HCC) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05862181
• Other study ID #: HCC-HEPA-HAIC-001
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: December 2023

Study information

• Verified date: March 2023
• Source: Peking University Cancer Hospital & Institute
• Contact: Xu Zhu, M.D
• Phone: 86-13501146178
• Email: drzhuxu[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Hepatocellular Carcinoma (HCC)
• Carcinoma
• Carcinoma, Hepatocellular

Intervention

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

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Cancer Hospital & Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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