Status:
COMPLETED
Emulsion Versus Suspension in Chemoembolization for Hepatocellular Carcinoma
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of the study was to evaluate the safety and efficacy of using the new formulation (Lipiodol-cisplatin suspension) for TACE in the treatment of HCC as compared to the conventional formulation (...
Detailed Description
Randomization with 1:1 ratio is centralized and performed by an independent statistician, it is stratified by the diameter of largest tumor less than or equal to 5cm or \> 5cm, and total number of tum...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Written informed consent
- Age above 18 years
- HCC unsuitable for resection or ablation
- Child-Pugh A cirrhosis
- Eastern Cooperative Oncology Group performance score 0 or 1
- BCLC A or B
- No previous treatment for HCC except for liver resection
- HCC diagnosed by typical enhancement patterns on cross sectional imaging or histology.
- No extra-hepatic involvement on non-enhanced CT thorax and triphasic contrast enhanced CT abdomen.
- No invasion of portal vein or hepatic vein
- Massive expansive tumor morphology with measurable lesion on CT (characterized by well-defined spherical or globular configuration, with or without tumor capsule or satellite lesions)
- Total tumor mass \< 50% liver volume
- Size of any individual tumor greater than or equal to 10cm in largest dimension
- Serum creatinine \< 130 umol/L or Creatinine clearance \> 55 ml/min.
- Exclusion criteria
- Known active malignancy within the last 3 years
- History of acute tumor rupture presenting with hemo-peritoneum
- Biliary obstruction not amenable to percutaneous or endoscopic drainage
- History of hepatic encephalopathy
- Intractable ascites not controllable by medical therapy
- History of variceal bleeding within last 3 months
- Infiltrative tumor morphology (characterized by ill- defined tumor margin and amorphous configuration) or diffuse tumor morphology (characterized by large number of small nodules)
- Un-correctable Arterio-portal venous shunt affecting \>1 hepatic segment on CT
- Arterial-hepatic venous shunt with hepatic vein opacified in arterial phase on CT
Exclusion
Key Trial Info
Start Date :
September 9 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03268499
Start Date
September 9 2016
End Date
April 28 2023
Last Update
November 15 2024
Active Locations (1)
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1
Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong, Hong Kong