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Combined Chemoembolization and Systemic Hyperthermia for Unresectable Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma

Status
Terminated
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
TACE with Hyperthermia Treatment
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 - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

TACE with Hyperthermia treatment

Arm Description

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

Outcomes

Primary Outcome Measures

dose limiting toxicity

Secondary Outcome Measures

adverse event of treatment
imaging evidence of objective tumor response
treatment response by alphafetoprotein

Full Information

First Posted
March 21, 2013
Last Updated
August 28, 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
NCT01817205
Brief Title
Combined Chemoembolization and Systemic Hyperthermia for Unresectable Hepatocellular Carcinoma
Official Title
A Pilot Study on the Feasibility of Combined Chemoembolization and Adjuvant Systemic Hyperthermia for Palliative Treatment of Unresectable Hepatocellular Carcinoma(HCC)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Terminated
Why Stopped
poor case accrual
Study Start Date
March 2013 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (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 is to evaluate the safety and therapeutic effect of combined hyperthermia and TACE for unresectable HCC
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.

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
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TACE with Hyperthermia treatment
Arm Type
Other
Arm Description
Interventions: TACE to all liver lesions and two sessions of systemic hyperthermia performed at 24 hours and 48 hours respectively after TACE.
Intervention Type
Procedure
Intervention Name(s)
TACE with Hyperthermia Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
dose limiting toxicity
Time Frame
30 days from the study treatment
Secondary Outcome Measure Information:
Title
adverse event of treatment
Time Frame
within 6 months of treatment
Title
imaging evidence of objective tumor response
Time Frame
3 and 6 months after treatment
Title
treatment response by alphafetoprotein
Time Frame
6 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
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 Clinical 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 Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Combined Chemoembolization and Systemic Hyperthermia for Unresectable Hepatocellular Carcinoma

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