The purpose of this multicenter registry is to gather the safety, efficacy and survival data in intermediate and advanced HCC patients treated drug-eluting microsphere in Taiwan in order to provide clinical evidence in HCC management to physicians in the region, and to support the application of deTACE in treating advanced HCC patients.
The purpose of this multicenter registry is to gather the safety, efficacy and survival data in intermediate and advanced HCC patients treated drug-eluting microsphere in Taiwan in order to provide clinical evidence on deTACE in HCC management to physicians in the region, and to support the application of in treating advanced HCC patients. 1. Primary Objective: To collect 1-year overall survival of chemoembolization with drug-eluting microsphere in intermediate and advanced HCC patients in Taiwan. 2. Secondary Objectives: 1. To evaluate the overall tumor response of chemoembolization with drug-eluting microsphere in intermediate and advanced HCC patients. The tumor response is according to Modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria. 2. To evaluate the local tumor response (in the tumor(s) treated with drug-eluting microsphere) by chemoembolization with drug-eluting microsphere in intermediate and advanced HCC patients. 3. To evaluate the safety profile of chemoembolization with drug-eluting microsphere in intermediate and advanced HCC patients. 3. Exploratory Objectives: 1. To evaluate the downstaging and downsizing potential of chemoembolization with drug-eluting microsphere in intermediate and advanced HCC patients to within Milan Criteria and to within Resection margin. 2. To collect time-to-progression (TTP) and progress-free-survival (PFS) data of chemoembolization with drug-eluting microsphere in intermediate and advanced HCC patients.
Study Type
OBSERVATIONAL
Enrollment
120
Taipei Veterans General Hospital
Taipei, Taiwan
RECRUITINGOverall survival
To define all participants from the day of the first HepaSphere Treatment until end of study or death is reported, whichever comes first.
Time frame: 1 year
Tumor Response
Tumor response will be assessed using modified Response Evaluation Criteria In Solid Tumors (mRECIST) criteria to evaluate tumor necrosis under CT/ MRI and will be presented as %.
Time frame: 1 year
Adverse Event (AE)
Adverse event will be accessed according to CTCAE 4.0 after treatments until end of study or death.
Time frame: 1 year
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