Doxorubicin Transdrug® in Advanced Hepatocellular Carcinoma.
- Conditions
- HepatoCellular CarcinomaCancer - Liver
- Registration Number
- ACTRN12608000082303
- Lead Sponsor
- ORION Clinical Services (Australia) Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 200
Patients with hepatocellular carcinoma (HCC); Multinodular hepatocellular carcinoma more than one lesion) regardless of the number of lesions, but involves less than 50% of the liver mass; Child-Pugh score A (assessment of the prognosis of chronic liver disease, mainly cirrhosis); Left ventricular ejection fraction (LVEF) greater than or equal to 50% as determined by echocardiography/cardiac ultrasound (the amount of blood pumped out of a ventricle with each heart beat); Adequate pulmonary function; Platelets greater than or equal to 75 x 109L; Absolute neutrophil count (white blood cells)greater than or equal to 1,0 x 109L; Aspartate transaminase (AST) and/or Alanine transaminase (ALT) less than or equal to 5 times upper limit of normal (liver enzymes, determine the health of the liver); Prothrombin time ratio greater than 60% and Factor V greater than 60% (measure of blood clotting ability).
Blood clots in the main blood vessels of the liver;
Risk for oesophageal bleeding;
Hepatocellular carcinoma developed on transplanted liver;
Presence of extra-hepatic metastases (cancer outside liver);
Patients able to benefit from hepatic transplantation, surgical resection, pure alcogol injection into tumour or radiofrequency ablation (tumour mass is heated by radiofrequency to a point where the cells die);
Patient having undergone a 450 mg/m² cumulated dose of doxorubicin;
Prior chemotherapy, transarterial chemoembolisation (TACE), embolisation, radiation therapy for hepatocellular carcinoma regardless of the time elapsed before the enrolment;
Patients who have benefited from surgical resection or percutaneous (alcohol and/or radiofrequency) treatment in the month preceding the enrolment;
Patients currently being treated with immunosuppressor agent (medication to suppress the immune system) and/or an anticoagulant (medication to thin your blood) that cannot be stopped;
Presence of cardiac abnormalities;
Patient with a life expectancy of less than 3 months;
Pregnant or breast-feeding women; Patients with mental deficiency preventing proper understanding of trial protocol requirements.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of patients free of local progression at 3 months after randomisation (treatment group).[3 months after randomisation];Number of patients free of local progression at 3 months after randomisation (control group).[3 months after randomisation]
- Secondary Outcome Measures
Name Time Method Comparison between the treated and control groups: progression free survival, overall survival, objective response rate, tolerance and quality of life[Every three months for 12 months and survivial until death.];To determine the pharmacokinetic profile of Doxorubicin Transdrug.[Detemrined at the end of the study.]