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

NCT03283956 — Unknown, 500 participants, National Taiwan University Hospital

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

Registry	NCT03283956, acronym SERENADE-T
Status	Unknown
Study type	Observational
Enrollment	500 (Estimated)
Sponsor	National Taiwan University Hospital (Other); collaborators: National Cheng-Kung University Hospital, Taichung Veterans General Hospital
Conditions	Hepatocellular Carcinoma Non-resectable, Chemoembolization, Therapeutic
Interventions	Patient records (Device)
Dates	start 2017-09-13 (estimated), primary completion 2018-08-31 (estimated), completion 2018-08-31 (estimated), first posted 2017-09-15, last updated 2017-09-15
Locations	1 site in Taiwan

-Summary

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

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Patient records		Device: Patient records	Medical records of all patients who underwent DC bead TACE.

Patient records (Device): 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

+Outcome measures

Primary outcomes

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 outcomes

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.

+Eligibility

Sex: All

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.

+Locations (1)

Facility	City	Country	Status
National Taiwan University Hospital	Taipei	Taiwan

+Investigators

Chien-Hung Chen, MD, Principal investigator, National Taiwan University Hospital