Evaluation of the efficacy and tolerance of Hepatic Intrarterial-Injection of Doxorubicin Transdrug® in Advanced Hepatocellular Carcinoma, to that of standard care. A Randomized, Multicentre Phase 2-3 Study.

ORION Clinical Services (Australia) Pty Ltd0 个研究点目标入组 200 人开始时间: 2008年2月13日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•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.

发起方

ORION Clinical Services (Australia) Pty Ltd