Ablative Chemoembolization for Unresectable and Large Hepatocellular Carcinoma

NCT03662841 | Terminated DMC

• 1 other identifier: VIR-18-08
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Carcinoma, Hepatocellular

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Tumor response

  3 to 6 months after treatment

Study Arms (1)

ACE for HCC of size >10cm

OTHER

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

Procedure: Ablative chemoembolization (ACE)

Interventions

Ablative chemoembolization (ACE) PROCEDURE

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

ACE for HCC of size >10cm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

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

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Simon Yu

  DIIR, CUHK, Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Use of ACE for HCC of size \> 10cm

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 10, 2018
• Study Start: July 13, 2018
• Primary Completion: April 17, 2023
• Study Completion: April 28, 2023
• Last Updated: May 3, 2023

Record last verified: 2022-02

Locations

HK (1)