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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN63349435

Enrollment

196

Registered

2004-09-30

Start date

2003-10-14

Completion date

Unknown

Last updated

2018-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver cancer Cancer Malignant neoplasm of liver

Interventions

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 administe

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1. Overall survival 2. Quality of life 3. Toxicity 4. Objective response rates	—

Secondary

Measure	Time frame
Not provided at time of registration	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026