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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, 2020
Sponsor:
Information provided by (Responsible Party):
Simon Yu, Chinese University of Hong Kong

Tracking Information
First Submitted Date  ICMJE September 6, 2018
First Posted Date  ICMJE September 10, 2018
Last Update Posted Date March 4, 2020
Actual Study Start Date  ICMJE July 13, 2018
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2018)		 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2018)		 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
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
Condition  ICMJE Carcinoma, Hepatocellular
Intervention  ICMJE Procedure: Ablative chemoembolization (ACE)
Ablative chemoembolization (ACE) using Lipiodol-ethanol and anhydrous cisplatin
Study Arms  ICMJE ACE for HCC of size >10cm
Ablative chemoembolization (ACE) using Lipiodol-ethanol and anhydrous cisplatin
Intervention: Procedure: Ablative chemoembolization (ACE)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 19, 2019)		 35
Original Estimated Enrollment  ICMJE
 (submitted: September 6, 2018)		 30
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Carmen Wong (852) 3505 3210 carmenwongsp@cuhk.edu.hk
Contact: Pui Man Chong (852) 3505 4094 siuman@cuhk.edu.hk
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Principal Investigator: Simon Yu DIIR, CUHK, Hong Kong
PRS Account Chinese University of Hong Kong
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP