Safety and Efficacy of dRug-ElutiNg beADs Trans-arterial chemoEmbolization for Hepatocellular Carcinoma in Taiwan

• Conditions: Hepatocellular Carcinoma Non-resectable; Chemoembolization, Therapeutic
• Interventions: Device: Patient records

• Registration Number: NCT03283956
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

To evaluate efficacy and safety profile of DC bead® TACE in patients with hepatocellular carcinoma in Taiwan.

Detailed Description

To evaluate efficacy and safety profile of DC bead TACE in patients with hepatocellular carcinoma in Taiwan.

This is a multi-center, retrospective, single arm study to explore safety and efficacy of DC bead TACE in hepatocellular carcinoma (HCC) in Taiwan

Retrospective analysis of medical records of all patients who underwent DC Bead TACE at National Taiwan University Hospital, National Cheng Kung University Hospital, and Taichung Veterans General Hospital from 2010-2017/7.

All statistical data were analyzed with SPSS software (SPSS, IBM North America, New York, NY, USA). Demographic and baseline lab data are presented by using descriptive statistics Student's t-test. Survival analysis will includes all patients.

Study Timeline

• Status Verified: 2017-09
• Study Start: 2017-09-13
• Study First Submitted: 2017-09-13
• Study First Submitted QC: 2017-09-13
• Last Update Submitted: 2017-09-13
• Study First Posted: 2017-09-15
• Last Update Posted: 2017-09-15
• Primary Completion: 2018-08-31
• Study Completion: 2018-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Patients with a diagnosis of HCC, according to the AASLD diagnosis criteria for HCC.
• Patient received DC bead TACE.

Exclusion Criteria

• Patients with current any other cancer except non-melanomatous skin cancer.
• Infiltrative HCC
• Patients received ≥2 consecutive sessions of TACE (≥2 TACE at the same admission, no matter it is cTACE or DC bead TACE)
• Patients received DC bead TACE and simultaneously received other therapy, such as radiotherapy, sorafenib etc.
• Presence of collateral vessel pathways potentially endangering normal territories during embolization.
• Presence of arteries supplying the lesion not large enough to accept DC Bead® microspheres.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient records	Patient records	Medical records of all patients who underwent DC bead TACE.

Primary Outcome Measures

Name	Time	Method
Safety of the DC bead TACE	One year.	Safety of the DC bead TACE is evaluated based on the incidence of Grade 3 and Grade 4 toxicities up to 8 weeks following the procedure according to National Cancer Institute's Common Terminology Criteria for adverse events (CTCAE Version 4.03).

Secondary Outcome Measures

Name	Time	Method
Tumor response	One year.	Tumor response is assessed on triphase CT or contrast-enhanced MR study according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan