Idarubicin hydrochloride for Hepatocellular carcinoma

Inclusion criteria

• {"criterion_text":"- Histologically-proven HCC or according to EASL criteria\n- Child-Pugh A or B7\n- Disease that is not suitable for resection, ablation or radiofrequency\n- Performance Status ECOG 0 or 1\n- BCLC A/B or C if Performance Status ECOG = 1\n- Measurable lesions according to mRECIST criteria\n- No previous treatment with chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy) or radioembolisation\n- Age superior or equal to 18 years\n- Platelets > 50,000/mm3, Polynuclear neutrophils > 1000/mm3, Creatininemia < 150umol/L, Bilirubinemia < 5 mg/dL\n- Absence of heart failure (Ultrasound LVEF > 50%)\n- Women of child-bearing age using an adequate method of contraception throughout treatment and 6.5 months after treatment\n- Men using an adequate method of contraception throughout the treatment and at least 3,5 months after the end of treatment\n- Written informed consent\n- National health insurance cover (France)"}

Exclusion criteria

• {"criterion_text":"- Advanced tumor disease (extrahepatic except pulmonary micronodules <7mm of tumoral portal vein thrombosis on positron emission tomography are not a contra-indication.)\n- Large HCC with liver invasion >50%\n- History of other cancer than HCC and excluding cancers known to have been cured for more than 5 years, or basocellular skin tumors or cervical cancer in situ treated with adequate and curative purpose\n- Advanced liver disease (Child B8, B9 or C)\n- Contra-indication for the MRI (Pacemaker or neurosensorial stimulator or implantable defibrillator, cochlear implant, ferromagnetic foreing body similar to the nervous structure)\n- Contra-indication to the injection of the gadolinium-based contrast agents (history of hypersensibility to the gadolinium chelates, meglumine).\n- Contra-indication to idarubicin (Hypersensibility to active substance or excipients, cardiopathy with myocardial insufficiency of less than 6 months, serious arrhythmias, serious renal or liver failure, yellow fever vaccine or any other live attenuated vaccine, persistente myelosuppression, previous treatments with idarubicin and/or other anthracyclines or anthracenediones at maximum cumulative doses, stomatitis)\n- Contra-indication to Lipiodol (Hypersensibility, proven hyperthyroidism, tromatic injuries, bleeding or recent bleeding)\n- Concomitant disease or uncontrolled severe clinical situation\n- Uncontrolled severe infection\n- Vascular anatomy makes it impossible to perform hepatic intra-arterial treatments\n- Grade 2 or 3 oesograstric varices on the last endoscopy less than 3 months old.\n- Pregnancy (Beta HCG positive) or breastfeeding\n- Patient who for psychological, social, family or geographical reasons cannot be followed regularly\n- Vulnerable person\n- Concomitant participation of the patient in another research involving the human person"}

Primary endpoints

• {"endpoint_text":"- Disease control rate (partial, complete or stable response) at 4 months after the first cycle of chemo-lipiodol using mRECIST criteria.","definition_or_measurement_approach":"Disease control assessed at 4 months after the first cycle using mRECIST criteria."}

Secondary endpoints

• {"endpoint_text":"- Time until treatment failure defined as the time interval between the inclusion date and the date of treatment failure. Patients alive without treatment failure will be censored on the latest news date. Treatment failure is defined as progression, the appearance of toxicities, or the inability to administer chemotherapy.","definition_or_measurement_approach":"Time from inclusion to treatment failure; censoring at last news for patients without failure. Treatment failure defined as progression, toxicity emergence, or inability to administer chemotherapy."}
• {"endpoint_text":"- Progression-free survival: defined as the time interval between the date of inclusion and the date of first progression or death (whatever the cause). Patients living without progress will be censored on the date of the last news.","definition_or_measurement_approach":"Time from inclusion to first progression or death; censor at last news if no progression."}
• {"endpoint_text":"- The rate of patients in objective response (complete response or partial response) at 6 months to from the date of the first course of chemo-lipiodol according to the mRECIST criteria evaluated according to the investigator and centralized proofreading","definition_or_measurement_approach":"Objective response rate at 6 months after first course per mRECIST, evaluated by investigator and centralized review."}
• {"endpoint_text":"- Tolérance defined by the NCI CTC AE v4.03 scale.","definition_or_measurement_approach":"Safety/tolerability assessed using NCI CTCAE v4.03 grading of adverse events."}
• {"endpoint_text":"- Quality of life questionnaire at 12 months after the first cycle of chemo-lipiodol at baseline, and 2, 4, 6, 12 months after the first cycle","definition_or_measurement_approach":"Quality of life measured with EORTC QLQ-C30 at baseline, 2, 4, 6 and 12 months after first cycle."}
• {"endpoint_text":"- The rate of thrombosis/hepatic arterial stenosis defined as the number of courses lasting which vascular thrombosis or stenosis is/are visible on arteriography initial hepatic artery(s), divided by the total number of cures.","definition_or_measurement_approach":"Rate calculated as number of courses with arteriographically visible hepatic arterial thrombosis/stenosis divided by total number of courses."}
• {"endpoint_text":"- Overall survival defined as the time interval between the date of inclusion and the date of death (all causes). Patients alive without progression will be censored on the date of latest news.","definition_or_measurement_approach":"Time from inclusion to death from any cause; censor at last news if alive."}

France

Earliest CTIS Part Ii Submission Date

13-06-2024

Latest Decision Or Authorization Date

21-03-2025

Processing Time Days

281

Number Of Sites

5

Number Of Participants

53

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Montpellier

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"France","full_name":"GUERBET","duties_or_roles":"Source of monetary support","organisation_type":""}