Ablative Chemoembolization for Unresectable and Large Hepatocellular Carcinoma
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ClinicalTrials.gov Identifier: NCT03662841 |
Recruitment Status :
Recruiting
First Posted : September 10, 2018
Last Update Posted : March 4, 2021
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Sponsor:
Chinese University of Hong Kong
Information provided by (Responsible Party):
Simon Yu, Chinese University of Hong Kong
Tracking Information | |||||||||
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First Submitted Date ICMJE | September 6, 2018 | ||||||||
First Posted Date ICMJE | September 10, 2018 | ||||||||
Last Update Posted Date | March 4, 2021 | ||||||||
Actual Study Start Date ICMJE | July 13, 2018 | ||||||||
Estimated Primary Completion Date | December 2023 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Time to progression [ Time Frame: 3 to 6 months after treatment ] the interval between the first treatment date and the date of radiological progression, including intralesional progression, extralesional progression, or extra-hepatic progression
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
Tumor response [ Time Frame: 3 to 6 months after treatment ] Tumor response at 3 month and 6 month from the date of first treatment as evaluated by triphasic contrast enhanced CT according to the EASL criteria
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Ablative Chemoembolization for Unresectable and Large Hepatocellular Carcinoma | ||||||||
Official Title ICMJE | Ablative Chemoembolization for Unresectable and Large Hepatocellular Carcinoma | ||||||||
Brief Summary | The objective of this study is to study the safety and tumor response of ACE for large HCC. | ||||||||
Detailed Description | Transarterial treatment has been playing an important role in the treatment algorithm for patients with multifocal or large intrahepatic hepatocellular carcinoma not eligible for surgical resection, transplantation, or local ablative therapy. Among the patient group with intermediate tumor stage, in which the tumor dimension exceeds 10cm, the treatment outcome of conventional chemoembolization (cTACE), chemoembolization using drug eluting beads (DEB-TACE) and radioembolization using yttrium 90 is generally unsatisfactory. Some would consider HCC of size >10cm a relative contraindication for cTACE because of the poor treatment outcome. However, there is no better alternative treatment for local control of these tumors. Ablative chemoembolization (ACE) using Lipiodol-ethanol and anhydrous cisplatin has been found to be highly effective for local control of HCC as compared to cTACE in a case-control study. It is hypothesized that ACE is safe and effective for local control of large HCC of size >10cm. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Use of ACE for HCC of size > 10cm Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Carcinoma, Hepatocellular | ||||||||
Intervention ICMJE | Procedure: Ablative chemoembolization (ACE)
Ablative chemoembolization (ACE) using Lipiodol-ethanol and anhydrous cisplatin
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Study Arms ICMJE | ACE for HCC of size >10cm
Ablative chemoembolization (ACE) using Lipiodol-ethanol and anhydrous cisplatin
Intervention: Procedure: Ablative chemoembolization (ACE)
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
35 | ||||||||
Original Estimated Enrollment ICMJE |
30 | ||||||||
Estimated Study Completion Date ICMJE | December 2023 | ||||||||
Estimated Primary Completion Date | December 2023 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 19 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Hong Kong | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03662841 | ||||||||
Other Study ID Numbers ICMJE | VIR-18-08 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Responsible Party | Simon Yu, Chinese University of Hong Kong | ||||||||
Study Sponsor ICMJE | Chinese University of Hong Kong | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Chinese University of Hong Kong | ||||||||
Verification Date | February 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |