Ablative Chemoembolization for Unresectable and Large Hepatocellular Carcinoma

  • STATUS
    Recruiting
  • End date
    Dec 16, 2023
  • participants needed
    35
  • sponsor
    Chinese University of Hong Kong
Updated on 14 February 2022
measurable disease
cirrhosis
chemoembolization
hepatectomy

Summary

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

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.

Details
Condition Carcinoma, Hepatocellular
Treatment Ablative chemoembolization (ACE)
Clinical Study IdentifierNCT03662841
SponsorChinese University of Hong Kong
Last Modified on14 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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