Transarterial Ethanol Ablation(TEA) for Unresectable Hepatocellular Carcinoma(HCC)

NCT ID: NCT01837381

Last Updated: 2019-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2017-07-31

Brief Summary

The objective of this trial was to evaluate the clinical outcome, treatment toxicity and tumor response of TEA for unresectable HCC.

Detailed Description

Transarterial therapy has been playing an important role in the treatment algorithm for patients with multifocal or large intrahepatic lesions not eligible for surgical resection, transplantation, or local ablative therapy. Among the various options of transarterial therapy including chemoembolization (TACE), bland embolization, radioembolization, and TEA, chemoembolization is the only one that has been proven to be of survival benefits versus best supportive care in randomized controlled trials. TEA is a hybrid of bland embolization and chemical ablation. Utilizing a liquid agent of Lipiodol-ethanol mixture consisting of 33% ethanol by volume, TEA offers complete and long lasting embolization of both the arterioles and portal venules supplying the tumor and could possibly be more effective than particulate embolic agents in tumor vessel embolization. The component of ethanol very likely offers synergistic effect to embolization and causes tumor ablation.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Transarterial Ethanol Ablation (TEA)

Two treatment sessions at 2 months apart were given and started within 4 weeks after randomization.

Group Type: OTHER

TEA

Intervention Type: PROCEDURE

Arterial feeders to tumors were identified and catheterized with a microcatheter to a branch supplying a Couinaud segment or subsegmental level for delivery of the therapeutic agent, which was Lipiodol-ethanol mixture at 2:1 ratio by volume for TEA (Lipiodol Ultrafluide, Guerbet, France; Dehydrated alcohol \[absolute alcohol\], Martindale Pharmaceuticals, United Kingdom). The agents were delivered under fluoroscopic control to completely fill up the vasculature of all tumors. The maximum total volume of Lipiodol-ethanol mixture or cisplatin emulsion to be delivered in one treatment session was 60 mL.

Interventions

TEA

Arterial feeders to tumors were identified and catheterized with a microcatheter to a branch supplying a Couinaud segment or subsegmental level for delivery of the therapeutic agent, which was Lipiodol-ethanol mixture at 2:1 ratio by volume for TEA (Lipiodol Ultrafluide, Guerbet, France; Dehydrated alcohol \[absolute alcohol\], Martindale Pharmaceuticals, United Kingdom). The agents were delivered under fluoroscopic control to completely fill up the vasculature of all tumors. The maximum total volume of Lipiodol-ethanol mixture or cisplatin emulsion to be delivered in one treatment session was 60 mL.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Signed informed consent by patient
• Age above 18 years
• Child-Pugh A or B cirrhosis
• Eastern Cooperative Oncology Group(ECOG) performance score 2 or below
• No serious concurrent medical illness
• No prior treatment or surgery for HCC
• Histologically or cytologically proven HCC except for lesions of size 1 to 2 cm, with typical features of HCC on two dynamic imaging techniques, or lesions larger than 2cm, with typical features on one dynamic imaging techniques, or lesions larger than 2cm with alpha feto protein(AFP) level > 200 ng/mL
• Unresectable disease without extra-hepatic involvement on chest X-ray(CXR) and CT
• Massive expansive tumor type with measurable lesion on CT
• Total tumor mass < 50% liver volume
• Tumor size ≤ 15cm in largest dimension
• Tumor number ≤ 5

Exclusion Criteria

• History of prior malignancy except on the condition that the patient has been disease free for ≥ 3 years
• Concurrent ischemic heart disease or heart failure
• History of acute tumor rupture presenting with hemo-peritoneum
• Serum creatinine level > 180 umol/L
• Biliary obstruction not amenable to percutaneous 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
• International normalized ratio(INR) > 1.5
• Extrahepatic metastasis
• Infiltrative or diffuse tumor
• Tumor number > 5
• Thrombosis of target hepatic artery
• Partial or complete thrombosis of the main portal vein; tumor invasion of portal branch of contralateral lobe
• Hepatic vein tumor thrombus
• Significant arterio-portal venous shunt
• Significant arterial-hepatic venous shunt

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prince of Wales Hospital, Shatin, Hong Kong

OTHER

Sponsor Role: collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Simon Yu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simon CH Yu, MD, FRCR

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Department of Clinicl Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, , Hong Kong

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

Hong Kong, , Hong Kong

Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

VIR-13-03

Identifier Type: -

Identifier Source: org_study_id