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

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

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

Study Overview

• Status: Unknown
• Conditions: Hepatocellular Carcinoma Non-resectable; Chemoembolization, Therapeutic
• Intervention / Treatment: Device: Patient records

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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Chien-Hung Chen, MD; Phone Number: 65923 886-2-23123456; Email: chenhcc@ntuh.gov.tw

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital
    • Contact: Chien-Hung Chen, MD; Phone Number: 65923 886-2-23123456; Email: chenhcc@ntuh.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient records; Medical records of all patients who underwent DC bead TACE.	Device: Patient records; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of the DC bead TACE	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).	One year.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: National Cheng-Kung University Hospital; Taichung Veterans General Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 13, 2017
• Primary Completion (Anticipated): August 31, 2018
• Study Completion (Anticipated): August 31, 2018

Study Registration Dates

• First Submitted: September 13, 2017
• First Submitted That Met QC Criteria: September 13, 2017
• First Posted (Actual): September 15, 2017

Study Record Updates

• Last Update Posted (Actual): September 15, 2017
• Last Update Submitted That Met QC Criteria: September 13, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: 201708028RINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No