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Hepatocellular CarcinomaNCT01837381

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

A study testing TEA in people with Hepatocellular Carcinoma, run by Chinese University of Hong Kong at 3 sites in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
TEA
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
3 sitesHong Kong
Study dates
Feb 2007to Jul 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

Hong Kong3 sites

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

    Hong Kong

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

    Hong Kong

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

    Hong Kong

Other trials in Hong Kong

About this study

Official title: A Comprehensive Analysis of Clinical Outcome, Treatment Toxicity and Tumor Response of Transarterial Ablation(TEA) for Unresectable Hepatocellular Carcinoma(HCC)

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

Read the 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.

Being tested
TEA
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TEAProcedure or surgery

    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.

Study groups in NCT01837381
Study groupRoleWhat they receive
Transarterial Ethanol Ablation (TEA)OtherTwo treatment sessions at 2 months apart were given and started within 4 weeks after randomization.
Receives: Procedure: TEA

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. 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.

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

  2. 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.

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

  3. 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.

    Measured: Tumor response is studied at 6 months after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2013 (estimated)
  2. Study startFeb 2007
  3. Primary completionJul 2017
  4. Study completionJul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01837381
Sponsor's protocol ID
VIR-13-03
Status last verified
Apr 2017
First submitted
15 Apr 2013
Last updated
3 Sep 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing TEA in people with Hepatocellular Carcinoma, run by Chinese University of Hong Kong at 3 sites in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall survival and treatment-related toxicity (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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01837381.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2019.

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