Back to resultsTACE Emulsion Versus Suspension
Primary Purpose
Hepatocellular Carcinoma
Status
Completed
Phase
Phase 2
Locations
Hong Kong
Study Type
Interventional
Intervention
Cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
Eligibility Criteria
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 <= 12cm 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
- Child-Pugh B or C cirrhosis
- 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)
- Incorrectable Arterio-portal venous shunt affecting >1 hepatic segment on CT
- Arterial-hepatic venous shunt with hepatic vein opacified in arterial phase on CT
Sites / Locations
- Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Lipiodol-cisplatin suspension
Lipiodol-cisplatin emulsion
Arm Description
Outcomes
Primary Outcome Measures
Time to progression (TTP)
The interval between the randomization date and the date of radiological progression, including intralesional progression, extralesional progression, or extra-hepatic progression.
Secondary Outcome Measures
Full Information
NCT ID
NCT03268499
First Posted
August 29, 2017
Last Updated
April 28, 2023
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT03268499
Brief Title
TACE Emulsion Versus Suspension
Official Title
Lipiodol-based Transcatheter Arterial Chemoembolization for Unresectable Hepatocellular Carcinoma: A Randomized Controlled Trial of Aqueous Cisplatin Emulsion Versus Cisplatin Particle Suspension
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 9, 2016 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
April 28, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 (Lipiodol-cisplatin emulsion). This is a prospective, parallel-group, open-label randomized, phase II study that is conducted in accordance to the Declaration of Helsinki and international standards of Good Clinical Practice, and approved by the institutional review board. Eligible patients were randomized into either a treatment arm of Lipiodol-cisplatin suspension or a control arm of Lipiodol-cisplatin emulsion with a 1:1 ratio.
Detailed Description
Transcatheter arterial chemoembolization (TACE) has been playing an important role in the treatment algorithm for patients with multifocal or large intrahepatic lesions not eligible for surgical resection, transplantation, or local ablative therapy. In Hong Kong, the TACE regimen currently being utilized in the great majority of hospitals is based on an aqueous form of cisplatin (1mg per mL) mixed in a one-to-one ratio by volume with Lipiodol to form a relatively large volume of 40mL emulsion at 20mg cisplatin as the maximum dose. Although TACE with this regimen has been shown to be effective in prolonging overall survival, there is probably room for further improvement because the objective tumor response rate is limited to 39%. One of the approaches to improve the treatment effectiveness of TACE could be to increase the dose of chemotherapeutic agent. In the United States, the most common regimen of chemotherapeutic agent in TACE is the mixture of cisplatin 100mg, doxorubicin 50mg, and mitomycin C 10mg, dissolved in 10ml of water-soluble contrast medium, then emulsified in an equivalent volume of lipiodol to form a 20mL emulsion. A relatively new regimen was introduced, in which a relatively high dose of cisplatin up to 100mg in particle form was given as a suspension in 20mL of Lipiodol, this regimen has been used and found to achieve an improved objective tumor response rate of 51%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lipiodol-cisplatin suspension
Arm Type
Active Comparator
Arm Title
Lipiodol-cisplatin emulsion
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
The procedure of TACE is the same irrespective of which regimen is used.
Primary Outcome Measure Information:
Title
Time to progression (TTP)
Description
The interval between the randomization date and the date of radiological progression, including intralesional progression, extralesional progression, or extra-hepatic progression.
Time Frame
within 30 days of a treatment procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 <= 12cm 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
Child-Pugh B or C cirrhosis
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)
Incorrectable Arterio-portal venous shunt affecting >1 hepatic segment on CT
Arterial-hepatic venous shunt with hepatic vein opacified in arterial phase on CT
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Yu
Organizational Affiliation
DIIR, CUHK, Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
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TACE Emulsion Versus Suspension
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