Combined Chemoembolization and Systemic Hyperthermia for Unresectable Hepatocellular Carcinoma

The Chinese University of Hong Kong

Status

Terminated

Conditions

Hepatocellular Carcinoma

Treatments

Procedure: TACE with Hyperthermia Treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT01817205

VIR-13-01

Details and patient eligibility

About

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

Full 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.

Enrollment

8 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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