A randomised, open label controlled trial of trans-arterial chemoembolisation vs embolisation alone in non-resectable hepatocellular carcinoma

Department of Health0 个研究点目标入组 196 人开始时间: 2004年9月30日最近更新: 2018年11月19日

适应症

试验速览

•Added 11/08/2009:
•1. Evidence of HCC as diagnosed by either histological means; or as evidenced by a focal lesion >2 cm with arterial hypervascularisation detected on two radiological studies (any two of ultrasound, CT, MRI or angiography) in a patient with a background of cirrhosis; or by a single radiological study with an a-fetoprotein greater than 400 ng/ml (1)
•2. The patient must not be a candidate for surgical resection of the tumour but may be suitable for transplantation
•3. The patient must have either a solitary hepatic tumour >3 cm in diameter or multifocal disease as evidenced by CT or MRI scanning.
•4. Aged =16 years and estimated life expectancy >3 months
•5. ECOG performance status = 2
•6. Adequate haematological function
•7. Adequate clotting function: INR = 1.5
•8. GFR = 50ml/min
•9. Adequate liver function
•10. Capable of giving written informed consent
•11. Women of child-bearing potential should have a negative pregnancy test prior to study entry AND be using an adequate contraception method, which must be continued for 3 months after completion of treatment

•Added 11/08/2009:
•1. Extra-hepatic metastases
•2. Prior treatment for HCC
•3. Active sepsis or bleeding
•4. Hepatic encephalopathy
•5. Ascites refractory to diuretic therapy
•6. Documented occlusion of the hepatic artery or portal vein
•7.Hypersensitivity to intravenous contrast agents
•8. Pregnant or lactating women
•9. History of prior malignancy
•10. Any evidence of severe or uncontrolled systemic diseases or laboratory finding
•11. Any psychiatric or other disorder (eg brain metastases) likely to impact on informed consent

发起方