Status:
COMPLETED
Transarterial Ethanol Ablation(TEA) for Unresectable Hepatocellular Carcinoma(HCC)
Lead Sponsor:
Chinese University of Hong Kong
Collaborating Sponsors:
Prince of Wales Hospital, Shatin, Hong Kong
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- Tumor size ≤ 15cm in largest dimension
- Tumor number ≤ 5
Exclusion
- 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
- International normalized ratio(INR) \> 1.5
- Extrahepatic metastasis
- Infiltrative or diffuse tumor
- Tumor number \> 5
- Thrombosis of target hepatic artery
- Partial or complete thrombosis of the main portal vein; tumor invasion of portal branch of contralateral lobe
- Hepatic vein tumor thrombus
- Significant arterio-portal venous shunt
- Significant arterial-hepatic venous shunt
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01837381
Start Date
February 1 2007
End Date
July 1 2017
Last Update
September 3 2019
Active Locations (3)
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1
Department of Clinicl 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 Chinsese University of Hong Kong
Hong Kong, Hong Kong
3
Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong, Hong Kong