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Ablative Chemoembolization for Unresectable and Large Hepatocellular Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03662841
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : March 4, 2020
Sponsor:
Information provided by (Responsible Party):
Simon Yu, Chinese University of Hong Kong

Study Description
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Brief Summary:
The objective of this study is to study the safety and tumor response of ACE for large HCC.

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Procedure: Ablative chemoembolization (ACE) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
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
Official Title: Ablative Chemoembolization for Unresectable and Large Hepatocellular Carcinoma
Actual Study Start Date : July 13, 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021
Arms and Interventions
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Arm Intervention/treatment
ACE for HCC of size >10cm
Ablative chemoembolization (ACE) using Lipiodol-ethanol and anhydrous cisplatin
 Procedure: Ablative chemoembolization (ACE)
Ablative chemoembolization (ACE) using Lipiodol-ethanol and anhydrous cisplatin


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signage of a written informed consent
  2. Age above 18 years
  3. HCC unsuitable for resection
  4. Child-Pugh A or B cirrhosis
  5. Eastern Cooperative Oncology Group performance score 0 or 1
  6. No previous treatment with liver resection, ablation, chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy),
  7. HCC diagnosed by typical enhancement patterns on cross sectional imaging or histology.
  8. No extra-hepatic involvement on non-enhanced CT thorax and triphasic contrast enhanced CT abdomen.
  9. No invasion of portal vein or hepatic vein
  10. 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)
  11. Total tumor mass < 50% liver volume
  12. Size of any individual tumor >10cm in largest dimension

Exclusion Criteria:

  1. History of acute tumor rupture presenting with hemo-peritoneum
  2. Biliary obstruction not amenable to percutaneous or endoscopic drainage
  3. Child-Pugh C cirrhosis
  4. History of hepatic encephalopathy
  5. Intractable ascites not controllable by medical therapy
  6. History of variceal bleeding within last 3 months
  7. Serum total bilirubin level > 50 umol/L
  8. Serum albumin level < 25g/L
  9. INR > 1.7
  10. Serum creatinine level > 150 mmol/L.
  11. Infiltrative tumor morphology (characterized by ill- defined tumor margin and amorphous configuration) or diffuse tumor morphology (characterized by large number of small nodules)
  12. Arterio-portal venous shunt affecting >1 hepatic segment on CT
  13. Arterial-hepatic venous shunt with hepatic vein opacified in arterial phase on CT
Contacts and Locations
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Information from the National Library of Medicine

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): NCT03662841


Contacts
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Contact: Carmen Wong (852) 3505 3210 carmenwongsp@cuhk.edu.hk
Contact: Pui Man Chong (852) 3505 4094 siuman@cuhk.edu.hk

Locations
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Hong Kong
Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Carmen Wong    (852)3505 3210    carmenwongsp@cuhk.edu.hk   
Contact: Pui Man Chong    (852)3505 4094    siuman@cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Simon Yu DIIR, CUHK, Hong Kong
More Information
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Responsible Party: Simon Yu, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03662841    
Other Study ID Numbers: VIR-18-08
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases