Overview

This trial is active, not recruiting.

Condition hepatocellular carcinoma
Treatment tea
Phase phase 2
Sponsor Chinese University of Hong Kong
Collaborator Prince of Wales Hospital, Shatin, Hong Kong
Start date February 2007
End date February 2017
Trial size 200 participants
Trial identifier NCT01837381, VIR-13-03

Summary

The objective of this trial was to evaluate the clinical outcome, treatment toxicity and tumor response of TEA for unresectable HCC.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Two treatment sessions at 2 months apart were given and started within 4 weeks after randomization.
tea
Arterial feeders to tumors were identified and catheterized with a microcatheter to a branch supplying a Couinaud segment or subsegmental level for delivery of the therapeutic agent, which was Lipiodol-ethanol mixture at 2:1 ratio by volume for TEA (Lipiodol Ultrafluide, Guerbet, France; Dehydrated alcohol [absolute alcohol], Martindale Pharmaceuticals, United Kingdom). The agents were delivered under fluoroscopic control to completely fill up the vasculature of all tumors. The maximum total volume of Lipiodol-ethanol mixture or cisplatin emulsion to be delivered in one treatment session was 60 mL.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Time to progression(TTP)
time frame: Time to progression is studied from treatment to disease progression, for an estimated period of up to 60 months.
Progression free survival(PFS)
time frame: 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
time frame: Tumor response is studied at 6 months after treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Comprehensive Analysis of Clinical Outcome, Treatment Toxicity and Tumor Response of Transarterial Ablation(TEA) for Unresectable Hepatocellular Carcinoma(HCC)
Principal investigator Simon CH Yu, MD, FRCR
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Chinese University of Hong Kong.