None listed
Conditions
Brief summary
The objective of the trial is to compare the efficacy (based on time to progression of tumour) and tolerance of Hepatic Intra-Arterial injection of Doxorubicin Transdrug® every 4 weeks, up to 3 courses with control standard treatment according to each centre’s usual practice (including TACE). This is an open label, multicentre, randomized in two parallel groups, Phase 2-3 study. The trial is designed to be performed in two successive parts, Phase 2 and Phase 3. At the end of the Phase 2, the efficacy of Doxorubicin Transdrug® will be evaluated based on the rate of patient free of local progression 3 months after randomisation. If more than 66% of patients treated with Doxorubicin Transdrug® are free of local progression, the study will be pursued and patients included in the Phase 2 study will automatically be followed and analyzed in the Phase 3 study. A total of 200 patients will be accrued of whom 50 patients will be accrued for the Phase 2. Patients satisfying inclusion and exclusion criteria will be centrally randomised to one of two treatments groups. Group A: Patients will receive a course of hepatic intra-arterial Doxorubicin Transdrug® on Day1. The treatment will be repeated every 4 weeks or until D90 (i.e. 3 months after randomization) for a total of 3 courses in the absence of disease progression or unacceptable toxicity. Group B: Patients will receive treatment according to each centre’s usual practice (including TACE), treatment will be repeated until D90 (i.e. 3 months after randomization) in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for one year.
Interventions
Hepatic Intrarterial-Injection of Doxorubicin Transdrug® at 30mg/m2. 3 courses, one course every 28 days.
Sponsors
ORION Clinical Services (Australia) Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
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).
Exclusion criteria
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.
Outcome results
None listed