Hepatocellular Carcinoma Clinical Trial
Official title:
Superselective Drug-Eluting Chemoembolization in Unresectable Intermediate and Advanced HCC Patients: Safety & Efficacy Registry in Taiwan (SUPER- Taiwan)
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.
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