Hepatocellular Carcinoma, non-resectable MedDRA version: 13.1 Level: LLT Classification code 10019828 Term: Hepatocellular carcinoma non-resectable System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria • Histological or cytological diagnosis or meet the AASLD criteria for diagnosis of HCC and at least one uni-dimensional lesion measurable according to the RECIST criteria by CT-scan or MRI. • Not a candidate for surgical resection • Aged = 18 years and estimated life expectancy >3 months • ECOG performance status = 1 • Adequate haematological function Hb = 9g/L, absolute neutrophil count =1.5x109/L, platelet count = 60x109/L • Bilirubin = 50 µmol/L, AST and ALT = 5 x ULN, ALP =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Extrahepatic metastasis • Prior embolisation, systemic or radiation therapy for HCC • Any contraindications for hepatic embolisation procedures procedures including portosystemic shunt, hepatofugal blood flow, known severe atheromatosis. • Investigational therapy or major surgery within 4 weeks of trial entry • Any ablative therapy (RFA or PEI ) for HCC (this should not exclude patients if target lesion(s) have not been treated and occurred >6 weeks prior study entry) • History of bleeding within the past 4 weeks • Child-Pugh cirrhosis C or B (score Grade 2 NCI-CTC version 4 • Pregnant or lactating women • Known history of HIV infection • 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 • Evidence of severe or uncontrolled systemic diseases, cardiac arrhythmias (requiring anti-arrhythmic therapy or pace maker), uncontrolled hypertension, congestive cardiac failure >NYHA class 2, 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 • Psychiatric or other disorder likely to impact on informed consent • Patient is unable and/or unwilling to comply with treatment and study instructions • Patient unable to swallow oral medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principal objective of this study is to determine whether the addition of sorafenib to TransArterial ChemoEmbolisation (TACE) performed with doxorubicin eluting beads, prolongs progression free survival in patients with unresectable Hepatocellular Carcinoma compared to TACE alone. TACE is the standard treatment for patients with liver cancer that cannot be removed by surgery. This procedure involves blocking the blood vessel that supplies the tumour with small particles and killing it by starving it of oxygen. These particles can be loaded with the chemotherapy drug doxorubicin which is delivered directly to the tumour and may increase the effectiveness of the procedure. Sorafenib is a relatively new anti-cancer treatment which is approved for use in the treatment of liver cancer. It works by slowing down the growth of cancer cells and it also slows the rate of new vessel formation on which tumour growth depends. As they work in different and complementary ways, combining th;Secondary Objective: There are a number of secondary objectives in this study. As stated, the principal objective looks specifically at progression free survival which is defined as the interval between the date of randomisation and the date of progression or death from any cause. A secondary objective of this study is to determine whether the combination therapy prolongs either the time to progression alone or the overall survival of patients. Both factors are of important significance but would require a larger sample size to form the principal objective. A realistically achievable recruitment target is crucial to a successful study and progression free survival was considered to be a suitable surrogate. The study will also assess whether the combination therapy has acceptable toxicity, the affect on disease response and the impact on patient Quality of Life. The study will measure whether it reduces the frequency for repeat TACE as measured by the number of TACE proce | — |
Countries
United Kingdom
Outcome results
None listed