Chemoembolization for Hepatocellular Carcinoma
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|ClinicalTrials.gov Identifier: NCT02821533|
Recruitment Status : Terminated (Poor case accrual)
First Posted : July 1, 2016
Last Update Posted : August 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Procedure: TACE Drug: Cisplatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Chemoembolization for Hepatocellular Carcinoma|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||August 2017|
|Actual Study Completion Date :||August 2017|
TACE using a high dose of cisplatin
Two consecutive treatments at two months apart will be given. A delay in the second treatment is allowed if patients do not recover to an acceptable state for subsequent cycle of treatment. Two treatment sessions at one month apart may be required for each complete treatment to cover all lesions when the lesions are diffusely distributed and involving both lobes.
TACE is performed under local anesthesia with right femoral puncture. The feeding lobar hepatic artery is selectively catheterized for drug delivery.
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.
Other Name: chemotherapeutic agent
- Tumor response [ Time Frame: 3 months after treatment ]CT scan abdomen will be performed 3 months after the first treatment. Tumor response by CT was classified into complete response (CR), partial response (PR), static disease (SD, and progressive disease (PD) according to European Association for the Study of the Liver (EASL) necrosis guidelines,
- overall survival [ Time Frame: 30 days after treatment ]No further treatment was given when there was deterioration in liver function or performance status meeting the exclusion criteria
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02821533
|Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong|
|Hong Kong, Hong Kong|
|Principal Investigator:||Simon Yu||DIIR, CUHK, Hong Kong|