Clinical trial NCT01837381: Transarterial Ethanol Ablation(TEA) for Unresectable Hepatocellular Carcinoma(HCC)
Official title: A Comprehensive Analysis of Clinical Outcome, Treatment Toxicity and Tumor Response of Transarterial Ablation(TEA) for Unresectable Hepatocellular Carcinoma(HCC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Prince of Wales Hospital, Shatin, Hong Kong
First posted: 2013-04-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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
* Tumor size ≤ 15cm in largest dimension
* Tumor number ≤ 5

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
* 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

Primary outcomes:
measure: overall survival and treatment-related toxicity
timeFrame: 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
Secondary outcomes:
measure: Time to progression(TTP)
timeFrame: Time to progression is studied from treatment to disease progression, for an estimated period of up to 60 months.
measure: Progression free survival(PFS)
timeFrame: Progression free survival is studied from treatment to disease progression or death from any cause, for an estimated period of up to 60 months.
measure: Tumor response
timeFrame: Tumor response is studied at 6 months after treatment
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Clinicl Oncology, Prince of Wales Hospital, The Chinese University of Hong Kong
city: Hong Kong
country: Hong Kong
facility: Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinsese University of Hong Kong
city: Hong Kong
country: Hong Kong
facility: Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Simon CH Yu, MD, FRCR
role: PRINCIPAL_INVESTIGATOR
References: