Advanced hepatocarcinoma (HCC)
Conditions
Interventions
Product Name: Doxorubicin Transdrug
Pharmaceutical Form: Powder for suspension for injection
INN or Proposed INN: Doxorubicin
CAS Number: 25316-40-9
Concentration unit: mg milligram(s)
Concentration t
Sponsors
BioAlliance Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: First part (phase 2) To evaluate the number of patient free of local progression assessed at 3 months after randomization in the Doxorubicin-Transdrug® treated group Second part (phase 3) To compare time to local progression between the two groups ;Secondary Objective: First part (phase 2) To evaluate the number of patient free of local progression assessed at 3 months after randomization for control group To determine pharmacokinetic profile of Doxorubicin-Transdrug® All the following secondary end-points will be based on a comparison between the treated and the control groups: - objective response rates according to EASL criteria - objective response rate according to RECIST criteria - tolerance Second part (phase 3) All the following secondary end-points will be based on a comparison between the treated and the control groups: - progression free survival - overall survival - objective response rates according to EASL criteria - objective response rate according to RECIST criteria - tolerance - quality of life;Primary end point(s): First part (phase 2): - The rate of Doxorubicin Transdrug®-treated patients free of local progression according to EASL criteria evaluated by spiral CT scan performed 3 months after randomization (M3). Second part (phase 3): - Time to local progression defined as the period between randomization and spiral CT scan showing documented progression, as confirmed by the external radiologist according to follow-up of 12 months according to EASL criteria. | — |
Countries
Germany
Outcome results
None listed