NCT01817205

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable hepatocellular-carcinoma

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 25, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

August 30, 2019

Status Verified

December 1, 2016

Enrollment Period

3.7 years

First QC Date

March 21, 2013

Last Update Submit

August 28, 2019

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • dose limiting toxicity

    30 days from the study treatment

Secondary Outcomes (3)

  • adverse event of treatment

    within 6 months of treatment

  • imaging evidence of objective tumor response

    3 and 6 months after treatment

  • treatment response by alphafetoprotein

    6 months after treatment

Study Arms (1)

TACE with Hyperthermia treatment

OTHER

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

TACE with Hyperthermia TreatmentPROCEDURE

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.

TACE with Hyperthermia treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +25 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Clinical 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 Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Diathermy

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Hyperthermia, InducedTherapeutics

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

March 21, 2013

First Posted

March 25, 2013

Study Start

March 1, 2013

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

August 30, 2019

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

HK(2)