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

NCT01837381 | Completed DMC

• 1 other identifier: VIR-13-03
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• overall survival and treatment-related toxicity

  Overall survival was defined as date of treatment to date of death from any cause. Patients alive at the end of follow-up were censored. Clinical and laboratory data were documented prospectively at baseline, during hospitalization, and at 7, 14, and 30 day, and 3, 6, 9, and 12 months. Laboratory findings were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.

  Overall survival is studied from treatment to death from any cause, for an estimated period of up to 60 months. Treatment-related toxicity is studied up to 3 months after treatment

Secondary Outcomes (3)

• Time to progression(TTP)

  Time to progression is studied from treatment to disease progression, for an estimated period of up to 60 months.

• Progression free survival(PFS)

  Progression free survival is studied from treatment to disease progression or death from any cause, for an estimated period of up to 60 months.

• Tumor response

  Tumor response is studied at 6 months after treatment

Study Arms (1)

Transarterial Ethanol Ablation (TEA)

OTHER

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

Procedure: TEA

Interventions

TEA 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.

Transarterial Ethanol Ablation (TEA)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Prince of Wales Hospital, Shatin, Hong Kong: collaborator

Study Sites (3)

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

Hong Kong, Hong Kong

Location

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

Hong Kong, Hong Kong

Location

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

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Tea

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

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Simon CH Yu, MD, FRCR

  Chinese University of 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

Study Record Dates

• First Submitted: April 15, 2013
• First Posted: April 23, 2013
• Study Start: February 1, 2007
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: September 3, 2019

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (3)