Combined Chemoembolization and Systemic Hyperthermia for Unresectable Hepatocellular Carcinoma

August 28, 2019 updated by: Simon Yu, Chinese University of Hong Kong

A Pilot Study on the Feasibility of Combined Chemoembolization and Adjuvant Systemic Hyperthermia for Palliative Treatment of Unresectable Hepatocellular Carcinoma(HCC)

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
dose limiting toxicity
Time Frame: 30 days from the study treatment
30 days from the study treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
adverse event of treatment
Time Frame: within 6 months of treatment
within 6 months of treatment
imaging evidence of objective tumor response
Time Frame: 3 and 6 months after treatment
3 and 6 months after treatment
treatment response by alphafetoprotein
Time Frame: 6 months after treatment
6 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Collaborators

Prince of Wales Hospital, Shatin, Hong Kong

Investigators

  • Principal Investigator: Simon CH Yu, MD, FRCR, Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

March 21, 2013

First Submitted That Met QC Criteria

March 21, 2013

First Posted (Estimate)

March 25, 2013

Study Record Updates

Last Update Posted (Actual)

August 30, 2019

Last Update Submitted That Met QC Criteria

August 28, 2019

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIR-13-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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