Patients with interemdiate-advanced stage hepatocarcinoma MedDRA version: 21.0 Level: LLT Classification code 10024662 Term: Liver cell carcinoma non-resectable System Organ Class: 100000004864
Conditions
Interventions
Trade Name: ZAVEDOS - 5 MG CAPSULE RIGIDE FLACONE DA 1 CAPSULA
Product Name: Zavedos
Product Code: 027441031
Pharmaceutical Form: Capsule, hard
Sponsors
CENTRO DI RIFERIMENTO ONCOLOGICO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with - Advanced hepatocarcinoma (BCLC-C) progressed or intolerant to Sorafenib, or when Sorafenib and Regorafenib is controindicated, or - intermediate hepatocarcinoma (BCLC-B) not suitable or not responsive to chemoembolization (TACE), who progressed or are intolerant to Sorafenib and Regorafenib or when Sorafenib and Regorafenib is controindicated • A-B7 Child-Pugh score • Measurable or evaluable disease according to RECIST v1.1 criteria • Age >/= 18. • ECOG PS = 0-1 • Adequate bone marrow, liver and renal functions 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 32 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: • Previous treatment with molecular target therapy with the exception of sorafenib. • Life expectancy < 2 months • clinically significant cardiovascular or cerebrovascular disease • clinically significant acute or chronic respiratory failure • History of previous tumors with DFS < 5 yrs with the exception of basocellular or spinocellular skin carcinoma, in situ carcinoma of the cervix, breast or bladder • grade = 1 according to CTCAE residual toxicity from previous treatment . • previous cumulative dose of 300 mg/m2 of doxorubicina or equivalent drug • patients who are candidates to second line therapy with Regorafenib
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 6 month overall survival evaluation in patients with intermediate-advanced hepatic carcinoma treated with metronomic IDA;Secondary Objective: - Evaluation of progression free survival (PFS) and time to progression (TTP) - Evaluation of safety and tolerability of Idarubicin - Evaluation of the impact of metronomic treatment with IDA on quality of life ;Primary end point(s): 6 month-overall survival;Timepoint(s) of evaluation of this end point: 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evaluation of progression free survival and time to progression; Evaluate the possible correlation between IDA and IDOLO Ctrough levels and haematologic toxicity (G>2) and response.; Evaluate proteomic and metabolomic biomarkers in patients treated with Idarubicin; Evaluate the effect of "immunogenic cell death";Timepoint(s) of evaluation of this end point: 2 years; 2 years; 2 years; 2 years | — |
Countries
Italy
Contacts
Public ContactS.O.C. Farmacologia Sperimentale e
Centro di Riferimento Oncologico (CRO) - IRCCS Aviano
Outcome results
None listed