Chemoembolization, Therapeutic, Hepatocellular Carcinoma Non-resectable
Conditions
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.
Interventions
DEVICEPatient 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
Sponsors
National Cheng-Kung University Hospital
Taichung Veterans General Hospital
National Taiwan University Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Taiwan
Contacts
Primary ContactChien-Hung Chen, MD
Outcome results
None listed