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

INTERVENTION: Current information as of 11/08/2009: Single centre phase III randomised controlled trial comparing trans‐arterial chemoembolisation vs embolisation alone 1. Treatment arm ‐ trans‐arterially administered cisplatin followed by embolisation 2. Control arm ‐ Embolisation only Initial information at time of registration: Single centre phase III randomised controlled trial comparing trans‐arterial chemoembolisation vs embolisation alone CONDITION: Liver cancer ; Cancer ; Malignant neoplasm of liver PRIMARY OUTCOME: 1. Overall survival; 2. Quality of life; 3. Toxicity; 4. Objective response rates SECONDARY OUTCOME: Not provided at time of registration INCLUSION CRITERIA: 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 pregn