Combined Chemoembolization and Systemic Hyperthermia for Unresectable Hepatocellular Carcinoma

Sponsor

Chinese University of Hong Kong (Other)

Overall Status

Terminated

CT.gov ID

NCT01817205

Collaborator

Prince of Wales Hospital, Shatin, Hong Kong (Other)

Enrollment

Locations

Arm

44.1

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Procedure: TACE with Hyperthermia Treatment	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2013

Actual Primary Completion Date :

Nov 1, 2016

Actual Study Completion Date :

Nov 1, 2016

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

dose limiting toxicity [30 days from the study treatment]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Clinical Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong	Hong Kong		Hong Kong
2	Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong	Hong Kong		Hong Kong

Sponsors and Collaborators

Chinese University of Hong Kong
Prince of Wales Hospital, Shatin, Hong Kong

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Simon Yu, Professor, Chinese University of Hong Kong

ClinicalTrials.gov Identifier:

NCT01817205

Other Study ID Numbers:

VIR-13-01

First Posted:

Mar 25, 2013

Last Update Posted:

Aug 30, 2019

Last Verified:

Dec 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Hepatocellular

Hyperthermia

Study Results

No Results Posted as of Aug 30, 2019