Ablative Chemoembolization for Unresectable and Large Hepatocellular Carcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-13

Study Completion Date

2023-04-28

Brief Summary

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

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Detailed Description

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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.

Conditions

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Carcinoma, Hepatocellular

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Use of ACE for HCC of size \> 10cm

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ACE for HCC of size >10cm

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

Group Type OTHER

Ablative chemoembolization (ACE)

Intervention Type PROCEDURE

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

Interventions

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Ablative chemoembolization (ACE)

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No