Ablative Chemoembolization for Unresectable and Large Hepatocellular Carcinoma

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Recruiting
CT.gov ID
NCT03662841
Collaborator
(none)
35
1
1
64.6
0.5

Study Details

Study Description

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
  • Procedure: Ablative chemoembolization (ACE)
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
35 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Use of ACE for HCC of size > 10cmUse 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 :
Jul 13, 2018
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: 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

Primary Outcome Measures

  1. Time to progression [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 [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

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong Hong Kong Hong Kong

Sponsors and Collaborators

  • Chinese University of Hong Kong

Investigators

  • Principal Investigator: Simon Yu, DIIR, CUHK, Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Simon Yu, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT03662841
Other Study ID Numbers:
  • VIR-18-08
First Posted:
Sep 10, 2018
Last Update Posted:
Mar 11, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 11, 2022