A Pilot Study on the Feasibility of Combined Chemoembolization and Adjuvant Systemic Hyperthermia for Palliative Treatment of Unresectable Hepatocellular Carcinoma(HCC)
18 Years
75 Years
Both
Hepatocellular Carcinoma
Trial Information
A Pilot Study on the Feasibility of Combined Chemoembolization and Adjuvant Systemic Hyperthermia for Palliative Treatment of Unresectable Hepatocellular Carcinoma(HCC)
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.
Inclusion Criteria:
Patient factor
- Age between 18 and 75
- Child-Pugh A cirrhosis
- 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
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
- 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
dose limiting toxicity
Outcome Time Frame:
30 days from the study treatment
Safety Issue:
Yes
Principal Investigator
Simon CH Yu, MD, FRCR
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Imaging and Interventional Radiology, The Chinese University of Hong Kong
Authority:
Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
Study ID:
VIR-13-01
NCT ID:
NCT01817205
Start Date:
March 2013
Completion Date:
Related Keywords:
- Hepatocellular Carcinoma
- Carcinoma
- Fever
- Carcinoma, Hepatocellular
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