Ablative Chemoembolization for Unresectable and Large Hepatocellular Carcinoma

Carcinoma, Hepatocellular Clinical Trial

Official title:

Ablative Chemoembolization for Unresectable and Large Hepatocellular Carcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03662841
• Other study ID #: VIR-18-08
• Status: Terminated
• Phase: N/A
• Start date: July 13, 2018
• Est. completion date: April 28, 2023

Study information

• Verified date: February 2022
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: April 28, 2023
• Est. primary completion date: April 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

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

Locations

Country	Name	City	State
Hong Kong	Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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