Status:
TERMINATED
Combined Chemoembolization and Systemic Hyperthermia for Unresectable Hepatocellular Carcinoma
Lead Sponsor:
Chinese University of Hong Kong
Collaborating Sponsors:
Prince of Wales Hospital, Shatin, Hong Kong
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
NA
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 show...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01817205
Start Date
March 1 2013
End Date
November 1 2016
Last Update
August 30 2019
Active Locations (2)
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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