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

NCT05862181 | Unknown

• 1 other identifier: HCC-HEPA-HAIC-001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Advanced Hepatocellular Carcinoma (HCC)

Keywords

HepaSphere; Transarterial chemoembolization; TACE; Hepatic Arterial Infusion Chemotherapy; HAIC

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Objective Response Rate (ORR)

  Up to 3 year

• Duration of Response (DoR)

  Up to 3 years

Study Arms (2)

HEPA-HAIC group

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

Procedure: DEB-TACE plus HAIC or HAIC alone

HAIC group

HAIC group is composed of advanced HCC patients treated with only HAIC as the interventional therapy

Procedure: DEB-TACE plus HAIC or HAIC alone

Interventions

DEB-TACE plus HAIC or HAIC alone PROCEDURE

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

HAIC group; HEPA-HAIC group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Central Study Contacts

Xu Zhu, M.D

CONTACT

86-13501146178; drzhuxu@163.com

Baojiang Liu, M.D

CONTACT

8618810321722; lbjjrk@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 17, 2023
• Study Start: January 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)