Doxorubicin-Transdrug® in Advanced HepatoCellular CarcinomaA Randomized, Multicenter Phase 2-3 Study. - DOTAHCC1

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 210

Inclusion Criteria

•18 to 80 years;
•Patients with hepatocellular carcinoma (HCC), diagnosed according to AASLD guidelines;
•Multinodular HCC regardless of the number of lesions, but with extension < 50% of the liver parenchyma;
•Child-Pugh stage A;
•Left ventricular ejection fraction (LVEF) = 50% as determine by echocardiograph;
•Adequate pulmonary function as measured by :
-a vital capacity (VC) > 70% of the theoretical
-a total lung capacity > 70% of the theoretical
-a carbon monoxide diffusing capacity (DLCO) > 70% of the theoretical and a DLCO/VA > 70% of the theoretical
-a forced expiratory volume in first second (FEV1)/ VC > 60%
-a SaO2 > 92% ;
•Platelets = 75 x 109 L;
•Absolute neutrophil count = 1,0 x 109 L;
•AST and/or ALT = 5 times upper limit of normal (NCI/CTC Grade 0, 1, 2);
•Prothrombin activity > 60% and V factor > 60%;
•ECOG score 0 - 2 ;
•Patients who have signed and dated written informed consent;
•Completed a period of at least 30 days since ending investigational device or drug trial;
•Women of childbearing potential should have highly effective contraception method (hormonal contraception, implantable contraceptive, injectable contraceptive double-barrier method or intrauterine device) required over 3 months prior and throughout the entire duration of the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Troncular or supra-hepatic vein thrombosis;
• Right and left lobar portal thrombosis;
•Risk for variceal bleeding diagnosed on a gastro-duodenal fibroscopy performed at least one year before enrolment and characterized by:
-Large esophageal varices or isolated cluster of varices in fundus of stomach
-Red wale marks (longitudinal red streaks on varices)
-Cherry-red spots (red, discrete, flat spots on varices)
-Hematocystic spots (red, discrete, raised spots)
-Diffuse erythema;
•HCC developed on a transplanted liver;
•Presence of extra-hepatic metastases;
•Patients able to benefit from a hepatic transplantation, surgical resection, percutaneous ethanol injection or radiofrequency ablation;
•Prior systemic chemotherapy, TACE, embolisation, radiation therapy for HCC regardless of the time elapsed before the enrolment;
•Patient having undergone a 450mg/m² cumulated dose of doxorubicin;
•Patients who has benefited from a surgical resection or percutaneous treatment in the month preceding the enrolment;
•Patient currently being treated by an immunosuppressor agent that cannot be stopped;
•Patient treated by an anticoagulant that cannot be stopped;
•Patient with unstable and developing medical-surgical problems;
•Presence of cardiac insufficiency, ongoing coronaropathy, arrhythmia or conduction disorders on the electrocardiogram;
•Patient with a life expectancy of less than 3 months;
•Pregnant or breast-feeding women;
•Patients with a mental deficiency preventing proper understanding of trial protocol requirements;
•Prior entry into this study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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