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

Phase 3

Completed

• Conditions: iver cancer; Cancer; Malignant neoplasm of liver

• Registration Number: ISRCTN63349435
• Lead Sponsor: Department of Health

Brief Summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23449352

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-09-30
• Study Completion: 2008-04-30
• Last Update Posted: 19 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 196

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 pregnancy test prior to study entry AND be using an adequate contraception method, which must be continued for 3 months after completion of treatment

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified