Combined Chemoembolization and Systemic Hyperthermia for Unresectable Hepatocellular Carcinoma

NCT ID: NCT01817205

Last Updated: 2019-08-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2016-11-30

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

TACE with Hyperthermia Treatment

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prince of Wales Hospital, Shatin, Hong Kong

OTHER

Sponsor Role: collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Simon Yu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simon CH Yu, MD, FRCR

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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

Countries

Hong Kong

Other Identifiers

VIR-13-01

Identifier Type: -

Identifier Source: org_study_id