A Pilot Study on the Feasibility of Combined Chemoembolization and Adjuvant Systemic Hyperthermia for Palliative Treatment of Unresectable Hepatocellular Carcinoma(HCC)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hepatocellular Carcinoma
- Sponsor
- Chinese University of Hong Kong
- Enrollment
- 8
- Locations
- 2
- Primary Endpoint
- dose limiting toxicity
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
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.
Investigators
Simon Yu
Professor
Chinese University of Hong Kong
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
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
Outcomes
Primary Outcomes
dose limiting toxicity
Time Frame: 30 days from the study treatment
Secondary Outcomes
- treatment response by alphafetoprotein(6 months after treatment)
- adverse event of treatment(within 6 months of treatment)
- imaging evidence of objective tumor response(3 and 6 months after treatment)