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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03283956
Other study ID # 201708028RINC
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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