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

Hepatocellular Carcinoma Non-resectable Clinical Trial

— SERENADE-T  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03283956
• Other study ID #: 201708028RINC
• Status: Not yet recruiting
• Phase: N/A
• First received: September 13, 2017
• Last updated: September 13, 2017
• Start date: September 13, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: September 2017
• Source: National Taiwan University Hospital
• Contact: Chien-Hung Chen, MD
• Phone: 886-2-23123456
• Email: chenhcc[@]ntuh.gov.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Chemoembolization, Therapeutic
• Hepatocellular Carcinoma Non-resectable

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (3)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Cheng-Kung University Hospital, Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.