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

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
TEA
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Clinicl Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong
  • Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinsese University of Hong Kong
  • Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Transarterial Ethanol Ablation (TEA)

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time to progression(TTP)
TTP was defined as date of treatment to date of first CT evidence of disease progression. Patient death during follow-up without CT progression was censored.
Progression free survival(PFS)
PFS was defined as date of treatment to date of either first CT evidence of disease progression or death from any cause. Patients alive and free of progression at the end of follow-up were censored.
Tumor response
Treatment response of individual treated tumor lesions was evaluated with CT and classified according to a system combining the recommendation of European Association for the Study of the Liver and the guidelines of World Health Organization, which was considered a preferred method of response assessment following transarterial or locoregional therapies for HCC. Tumor response was classified into 4 categories: 1) complete response (CR), 2) partial response (PR), 3) static disease (SD), or 4) intralesional progression.

Full Information

First Posted
April 15, 2013
Last Updated
August 29, 2019
Sponsor
Chinese University of Hong Kong
Collaborators
Prince of Wales Hospital, Shatin, Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT01837381
Brief Title
Transarterial Ethanol Ablation(TEA) for Unresectable Hepatocellular Carcinoma(HCC)
Official Title
A Comprehensive Analysis of Clinical Outcome, Treatment Toxicity and Tumor Response of Transarterial Ablation(TEA) for Unresectable Hepatocellular Carcinoma(HCC)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
Collaborators
Prince of Wales Hospital, Shatin, Hong Kong

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transarterial Ethanol Ablation (TEA)
Arm Type
Other
Arm Description
Two treatment sessions at 2 months apart were given and started within 4 weeks after randomization.
Intervention Type
Procedure
Intervention Name(s)
TEA
Intervention Description
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.
Primary Outcome Measure Information:
Title
overall survival and treatment-related toxicity
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Time to progression(TTP)
Description
TTP was defined as date of treatment to date of first CT evidence of disease progression. Patient death during follow-up without CT progression was censored.
Time Frame
Time to progression is studied from treatment to disease progression, for an estimated period of up to 60 months.
Title
Progression free survival(PFS)
Description
PFS was defined as date of treatment to date of either first CT evidence of disease progression or death from any cause. Patients alive and free of progression at the end of follow-up were censored.
Time Frame
Progression free survival is studied from treatment to disease progression or death from any cause, for an estimated period of up to 60 months.
Title
Tumor response
Description
Treatment response of individual treated tumor lesions was evaluated with CT and classified according to a system combining the recommendation of European Association for the Study of the Liver and the guidelines of World Health Organization, which was considered a preferred method of response assessment following transarterial or locoregional therapies for HCC. Tumor response was classified into 4 categories: 1) complete response (CR), 2) partial response (PR), 3) static disease (SD), or 4) intralesional progression.
Time Frame
Tumor response is studied at 6 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon CH Yu, MD, FRCR
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinicl Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
Facility Name
Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinsese University of Hong Kong
City
Hong Kong
Country
Hong Kong
Facility Name
Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No

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

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