A Comprehensive Analysis of Clinical Outcome, Treatment Toxicity and Tumor Response of Transarterial Ablation(TEA) for Unresectable Hepatocellular Carcinoma(HCC)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hepatocellular Carcinoma
- Sponsor
- Chinese University of Hong Kong
- Enrollment
- 200
- Locations
- 3
- Primary Endpoint
- overall survival and treatment-related toxicity
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The objective of this trial was to evaluate the clinical outcome, treatment toxicity and tumor response of TEA for unresectable HCC.
Detailed Description
Transarterial therapy has been playing an important role in the treatment algorithm for patients with multifocal or large intrahepatic lesions not eligible for surgical resection, transplantation, or local ablative therapy. Among the various options of transarterial therapy including chemoembolization (TACE), bland embolization, radioembolization, and TEA, chemoembolization is the only one that has been proven to be of survival benefits versus best supportive care in randomized controlled trials. TEA is a hybrid of bland embolization and chemical ablation. Utilizing a liquid agent of Lipiodol-ethanol mixture consisting of 33% ethanol by volume, TEA offers complete and long lasting embolization of both the arterioles and portal venules supplying the tumor and could possibly be more effective than particulate embolic agents in tumor vessel embolization. The component of ethanol very likely offers synergistic effect to embolization and causes tumor ablation.
Investigators
Simon Yu
Professor
Chinese University of Hong Kong
Eligibility Criteria
Inclusion Criteria
- •Signed informed consent by patient
- •Age above 18 years
- •Child-Pugh A or B cirrhosis
- •Eastern Cooperative Oncology Group(ECOG) performance score 2 or below
- •No serious concurrent medical illness
- •No prior treatment or surgery for HCC
- •Histologically or cytologically proven HCC except for lesions of size 1 to 2 cm, with typical features of HCC on two dynamic imaging techniques, or lesions larger than 2cm, with typical features on one dynamic imaging techniques, or lesions larger than 2cm with alpha feto protein(AFP) level \> 200 ng/mL
- •Unresectable disease without extra-hepatic involvement on chest X-ray(CXR) and CT
- •Massive expansive tumor type with measurable lesion on CT
- •Total tumor mass \< 50% liver volume
Exclusion Criteria
- •History of prior malignancy except on the condition that the patient has been disease free for ≥ 3 years
- •Concurrent ischemic heart disease or heart failure
- •History of acute tumor rupture presenting with hemo-peritoneum
- •Serum creatinine level \> 180 umol/L
- •Biliary obstruction not amenable to percutaneous drainage
- •Child-Pugh C cirrhosis
- •History of hepatic encephalopathy
- •Intractable ascites not controllable by medical therapy
- •History of variceal bleeding within last 3 months; serum total bilirubin level ≥ 50 umol/L
- •Serum albumin level \< 25g/L
Outcomes
Primary Outcomes
overall survival and treatment-related toxicity
Time Frame: Overall survival is studied from treatment to death from any cause, for an estimated period of up to 60 months. Treatment-related toxicity is studied up to 3 months after treatment
Overall survival was defined as date of treatment to date of death from any cause. Patients alive at the end of follow-up were censored. Clinical and laboratory data were documented prospectively at baseline, during hospitalization, and at 7, 14, and 30 day, and 3, 6, 9, and 12 months. Laboratory findings were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.
Secondary Outcomes
- Time to progression(TTP)(Time to progression is studied from treatment to disease progression, for an estimated period of up to 60 months.)
- Progression free survival(PFS)(Progression free survival is studied from treatment to disease progression or death from any cause, for an estimated period of up to 60 months.)
- Tumor response(Tumor response is studied at 6 months after treatment)