Study to assess efficacy and safety of the medication named Idarubicin given orally every other day to patients with advanced tumor of the liver who progressed or are intoelrant to the medication Sorafenib and Regorafenib

Phase 1

• Conditions: Patients with interemdiate-advanced stage hepatocarcinoma; MedDRA version: 21.0Level: LLTClassification code 10024662Term: Liver cell carcinoma non-resectableSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2017-003653-42-IT
• Lead Sponsor: CENTRO DI RIFERIMENTO ONCOLOGICO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-07
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 47

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)<br>- Evaluation of safety and tolerability of Idarubicin<br>- Evaluation of the impact of metronomic treatment with IDA on quality of life <br>;Primary end point(s): 6 month-overall survival;Timepoint(s) of evaluation of this end point: 2 years

Secondary Outcome Measures

Name	Time	Method
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