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TerminatedNCT01817205Updated Aug 30, 2019

Combined Chemoembolization and Systemic Hyperthermia for Unresectable Hepatocellular Carcinoma

An interventional study of TACE with Hyperthermia Treatment in Hepatocellular Carcinoma, sponsored by Chinese University of Hong Kong. Terminated at 2 sites in Hong Kong. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-08-30.

Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment

Why this study was terminated
poor case accrual
Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The objective is to evaluate the safety and therapeutic effect of combined hyperthermia and TACE for unresectable HCC

Read the detailed description

Most patients with Hepatocellular carcinoma (HCC) are diagnosed at an intermediate and advanced stage when the tumors become unresectable. Transcatheter arterial chemoembolization (TACE) has been shown to be effective in prolongation of survival for patients with unresectable HCC and generally adopted as a standard palliative treatment option for patients with intermediate stage HCC. However, the therapeutic effect of TACE in terms of objective tumor response is variable and modest (27%-40%), indicating that there is actually much room for improvement in the treatment. In many cases, patients with intrahepatic HCC uncontrolled after TACE treatment may not be suitable for other treatment options because of their physical condition. For these patients, repeat TACE combined with adjuvant systemic hyperthermia may offer a chance of disease control.

02

Conditions studied

  • Hepatocellular Carcinoma
03

In context

Carcinoma, Hepatocellular

3,249 studies on the registry are indexed under Carcinoma, Hepatocellular; 974 are open to participants now.

This study's enrollment of 8 is below the median of 55 across 2,347 interventional studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

Chinese University of Hong Kong is the lead sponsor of 1,446 studies on the registry; 467 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patient factor

  • Age between 18 and 75
  • Child-Pugh A cirrhosis
  • Eastern Cooperative Oncology Group(ECOG) performance status Grade 2 or below
  • No serious concurrent medical illness
  • Prior treatment for HCC including surgery, local ablation, or transarterial treatments allowed
  • Imaging evidence of poor intralesional treatment response or disease progression despite transarterial treatment
  • Platelet count ≥ 50 10\^9/L

Tumor factor

  • HCC diagnosed by typical enhancement patterns on cross sectional imaging or histology
  • Unresectable and locally advanced disease without extra-hepatic disease
  • Hypervascular lesions on CT
  • Greatest dimension of the largest tumor ≤15cm

Exclusion criteria

Exclusion Criteria:

Patient factor

  • History of significant concurrent medical illness such as ischemic heart disease or heart failure
  • Metallic body implants, not including dental fillings
  • Serum creatinine level > 130 umol/L
  • Presence of biliary obstruction not amenable to drainage
  • Child-Pugh B or C cirrhosis
  • Unable to give consent

Evidence of impaired liver function

  • History of hepatic encephalopathy
  • Intractable ascites not controllable by medical therapy
  • History of variceal bleeding within last 3 months
  • Serum total bilirubin level >25 umol/L for the first 5 patients, serum total bilirubin level >35 umol/L for the second 5 patients
  • Serum albumin level \< 30g/L
  • International normalized ratio(INR) >1.3

Tumor factor

  • Presence of extrahepatic metastasis
  • Infiltrative lesion

Vascular invasion

  • Hepatic artery thrombosis
  • Partial or complete thrombosis of the main portal vein
  • Tumor invasion of portal branch of contralateral lobe
  • Hepatic vein tumor thrombus
  • Significant arterioportal shunt
  • Significant arteriovenous shunt

Contraindication for hyperthermia

  • Known brain metastasis
  • Recent stroke or cerebral hemorrhage within last 6 months
  • Poorly controlled epilepsy
  • Poorly controlled cardiac arrhythmias
  • Myocardial infarction within last 6 months
  • Unstable angina within last 6 months
  • Poorly controlled hypertension
  • Poorly controlled diabetes
  • History of malignant hyperthermia
  • Photodermatosis
  • Pregnancy
  • Lactation
  • Serious infection
  • Grade 3 or above adverse event in serological total bilirubin or albumin according to Version 4.0 of National Cancer Institute Common Terminology Criteria for Adverse Events
  • Elevation of serum alanine transaminase ≥ 10 times upper limit of normal
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Other
    TACE with Hyperthermia treatment

    Interventions: TACE to all liver lesions and two sessions of systemic hyperthermia performed at 24 hours and 48 hours respectively after TACE.

    Procedure: TACE with Hyperthermia Treatment

Interventions

  • ProcedureTACE with Hyperthermia Treatment

    Transcatheter arterial chemoembolization (TACE) is performed under local anesthesia with right femoral puncture. The feeding lobar hepatic artery is selectively catheterized for drug delivery. Systemic hyperthermia is induced with an external energy source using microwave electromagnetic energy, with the patient lying supine on the treatment bed of the hyperthermia equipment, exposing the abdomen to the microwave transmitter.

06

What researchers measure

Primary outcomes

  1. dose limiting toxicity

    Time frame: 30 days from the study treatment

Secondary outcomes

  1. adverse event of treatment

    Time frame: within 6 months of treatment

  2. imaging evidence of objective tumor response

    Time frame: 3 and 6 months after treatment

  3. treatment response by alphafetoprotein

    Time frame: 6 months after treatment

07

Study locations

2 sites
  • Department of Clinical 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 Chinese University of Hong Kong
    Hong Kong, Hong Kong
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2013, a primary completion of Nov 2016 and a completion of Nov 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 21, 2013
First posted
Mar 25, 2013
Start
Mar 2013
Primary completionActual
Nov 2016
CompletionActual
Nov 2016
Last update
Aug 30, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01817205
Collaborators
Prince of Wales Hospital, Shatin, Hong Kong
Responsible party
Simon Yu (Professor, Chinese University of Hong Kong) — Principal investigator
First posted
Mar 25, 2013
Start date
Mar 2013
Primary completion
Nov 2016
Completion
Nov 2016
Last update
Aug 30, 2019

Study contacts

Simon CH Yu, MD, FRCR
principal investigator · Chinese University of Hong Kong

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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