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Ablative Chemoembolization for Unresectable and Large Hepatocellular Carcinoma

Primary Purpose

Carcinoma, Hepatocellular

Status

Terminated

Phase

Not Applicable

Locations

Hong Kong

Study Type

Interventional

Intervention

Ablative chemoembolization (ACE)

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

ACE for HCC of size >10cm

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT03662841

First Posted

September 6, 2018

Last Updated

April 28, 2023

Sponsor

Chinese University of Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT03662841

Brief Title

Ablative Chemoembolization for Unresectable and Large Hepatocellular Carcinoma

Official Title

Ablative Chemoembolization for Unresectable and Large Hepatocellular Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Terminated

Why Stopped

poor patient accrual

Study Start Date

July 13, 2018 (Actual)

Primary Completion Date

April 17, 2023 (Actual)

Study Completion Date

April 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Hepatocellular

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Use of ACE for HCC of size > 10cm

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ACE for HCC of size >10cm

Arm Type

Other

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Ablative chemoembolization (ACE)

Intervention Description

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

Primary Outcome Measure Information:

Title

Time to progression

Description

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 Outcome Measure Information:

Title

Tumor response

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Simon Yu

Organizational Affiliation

DIIR, CUHK, Hong Kong

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Hong Kong

Country

Hong Kong

12. IPD Sharing Statement

Learn more about this trial

Ablative Chemoembolization for Unresectable and Large Hepatocellular Carcinoma

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