Ablative Chemoembolization for Unresectable and Large Hepatocellular Carcinoma

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

Study Overview

• Status: Terminated
• Conditions: Carcinoma, Hepatocellular
• Intervention / Treatment: Procedure: Ablative chemoembolization (ACE)

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: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 to 6 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 to 6 months after treatment

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2018
• Primary Completion (Actual): April 17, 2023
• Study Completion (Actual): April 28, 2023

Study Registration Dates

• First Submitted: September 6, 2018
• First Submitted That Met QC Criteria: September 6, 2018
• First Posted (Actual): September 10, 2018

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: VIR-18-08

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No