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TerminatedNCT03662841Updated May 3, 2023

Ablative Chemoembolization for Unresectable and Large Hepatocellular Carcinoma

An interventional study of Ablative chemoembolization (ACE) in Carcinoma, Hepatocellular, sponsored by Chinese University of Hong Kong. Terminated at 1 site in Hong Kong. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2023-05-03.

Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment

Why this study was terminated
poor patient accrual
Phase
Not applicable
Study type
Interventional
Enrollment
11
Allocation
Not applicable
Ages
19 Years and older
Sex
All
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Study summary

The objective of this study is to study the safety and tumor response of ACE for large HCC.

Read the 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.

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Conditions studied

  • Carcinoma, Hepatocellular
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In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.

This study's enrollment of 11 is below the median of 45 across 5,174 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years and older
Sexes eligible
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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Other
    ACE for HCC of size >10cm

    Ablative chemoembolization (ACE) using Lipiodol-ethanol and anhydrous cisplatin

    Procedure: Ablative chemoembolization (ACE)

Interventions

  • ProcedureAblative chemoembolization (ACE)

    Ablative chemoembolization (ACE) using Lipiodol-ethanol and anhydrous cisplatin

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What researchers measure

Primary outcomes

  1. Time to progression

    the interval between the first treatment date and the date of radiological progression, including intralesional progression, extralesional progression, or extra-hepatic progression

    Time frame: 3 to 6 months after treatment

Secondary outcomes

  1. Tumor response

    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

    Time frame: 3 to 6 months after treatment

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Study locations

1 site
  • Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong
    Hong Kong, Hong Kong
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03662841
Lead sponsor
Chinese University of Hong Kong
Responsible party
Simon Yu (Professor, Chinese University of Hong Kong) — Principal investigator
First posted
Sep 10, 2018
Start date
Jul 13, 2018
Primary completion
Apr 17, 2023
Completion
Apr 28, 2023
Last update
May 3, 2023

Study contacts

Simon Yu
principal investigator · DIIR, CUHK, Hong Kong

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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