Evaluating sorafenib in combination with transarterial chemoembolisation (TACE) in patients with unresectable hepatocellular carcinoma (HCC)

Phase 3

Completed

• Conditions: Topic: National Cancer Research Network; Subtopic: Upper Gastro-Intestinal Cancer; Disease: Liver; Cancer; Hepatocellular carcinoma

• Registration Number: ISRCTN93375053
• Lead Sponsor: niversity College London (UCL) (UK)

Brief Summary

2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28648803 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-18
• Study Completion: 2016-08-31
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 313

Inclusion Criteria

1. Histological or cytological diagnosis or meet the American Association for the Study of Liver Diseases (AASLD) criteria for diagnosis of HCC and at least one uni-dimensional lesion measurable according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria by computed tomography (CT) scan or magnetic resonance imaging (MRI)
2. Not a candidate for surgical resection
3. Aged greater than or equal to 18 years and estimated life expectancy greater than 3 months
4. Eastern Cooperative Oncology Group (ECOG) performance status greater than or equal to 1
5. Adequate haematological function Hb greater than or equal to 9 g/L, absolute neutrophil count greater than or equal to 1.5 x 10^9/L, platelet count greater than or equal to 60 x 10^9/L
6. Bilirubin greater than or equal to 50 µmol/L, asparate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 5 x upper limit of normal (ULN), alkaline phosphatase (ALP) less than 4 x ULN
7. Adequate renal function; creatinine less than or equal to 1.5 x ULN
8. International normalised ratio (INR) greater than or equal to 1.5
9. Amylase and lipase less than 2 x ULN
10. Child-Pugh A (score less than or equal to 6)
11. Left ventricular ejection fraction greater than or equal to 45%
12. Women of child-bearing potential should have a negative pregnancy test prior to study entry. Both men and women must be using an adequate contraception method, which must be continued for 3 months after completion of treatment.
13. Written informed consent
14. Male and female, lower age limit of 18 years

Exclusion Criteria

1. Extrahepatic metastasis
2. Prior embolisation, systemic or radiation therapy for HCC
3. Any contraindications for hepatic embolisation procedures procedures including portosystemic shunt, hepatofugal blood flow, known severe atheromatosis
4. Investigational therapy or major surgery within 4 weeks of trial entry
5. Any ablative therapy (radiofrequency ablation [RFA] or percutaneous ethanol injection [PEI]) for HCC (this should not exclude patients if target lesion(s) have not been treated and occurred greater than 6 weeks prior study entry)
6. History of bleeding within the past 4 weeks
7. Child-Pugh cirrhosis C or B (score greater than or equal to 7)
8. Hepatic encephalopathy
9. Ascites refractory to diuretic therapy
10. Documented occlusion of the hepatic artery or main portal vein
11. Hypersensitivity to intravenous contrast agents
12. Active clinically serious infection greater than grade 2 National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.0
13. Pregnant or lactating women
14. Known history of human immunodeficiency virus (HIV) infection
15. History of second malignancy except those treated with curative intent more than three years preciously without relapse and non-melanotic skin cancer or cervical carcinoma in situ
16. Evidence of severe or uncontrolled systemic diseases, cardiac arrhythmias (requiring anti-arrhythmic therapy or pace maker), uncontrolled hypertension, congestive cardiac failure greater than New York Heart Association (NYHA) class 2, myocardial infarction (MI) within 6 months or laboratory finding that in the view of the Investigator makes it undesirable for the patient to participate in the trial
17. Psychiatric or other disorder likely to impact on informed consent
18. Patient is unable and/or unwilling to comply with treatment and study instructions
19. Patient unable to swallow oral medications

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS)

Secondary Outcome Measures

Name	Time	Method
Overall survival - the time between the date of randomisation and death from any cause