Chemoembolization for Hepatocellular Carcinoma
NCT02821533 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2017-08-22
Summary
The aim of the current study is to study the safety and effectiveness of TACE using a high dose of cisplatin for treatment of HCC. It is hypothesized that the formulation is safe and it improves the therapeutic effect of conventional TACE.
Conditions
Interventions
- PROCEDURE
-
TACE
TACE is performed under local anesthesia with right femoral puncture. The feeding lobar hepatic artery is selectively catheterized for drug delivery.
- DRUG
-
Cisplatin will be mixed with a mixture of Lipiodol and ethanol (LEM), which consists of 33% ethanol by volume in Lipiodol, in a ratio of 2mg cisplatin per mL of LEM, and delivered through catheters or microcatheters to the tumors until there is flow reduction at the tumor feeders. The total dose of cisplatin given in each treatment session is limited to 100mg (50mL LEM) in each treatment session. The usual volume of LEM delivered will be 20 - 30 mL.
Sponsors & Collaborators
-
Chinese University of Hong Kong
lead OTHER
Principal Investigators
-
Simon Yu · DIIR, CUHK, Hong Kong
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-02-29
- Primary Completion
- 2017-08-31
- Completion
- 2017-08-31
Countries
- Hong Kong
Study Locations
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