Hepatocellular Carcinoma on Cirrhosis With Child A/B7 and Hepatic Intra Arterial Injection of Idarubicin/Lipiodol Emulsion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-19

Study Completion Date

2026-06-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The investigators propose in this trial to test a hepatic chemotherapy, consisting of the hepatic intra-arterial injection Idarubicin, emulsified with Lipiodol, lipid vector, without embolization in the treatment of non-metastatic, unresectable hepatocellular carcinoma on cirrhosis with Child-Pugh A/B7.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Impact on Hepatic Recurrence After Adjuvant Chemotherapy With Intraarterial Infusion of Idarubicin-Lipiodol

NCT04178642

Hepatocellular Carcinoma

WITHDRAWN PHASE2

Chemoembolisation of Hepatocellular Carcinomas Not Subject to Interventive Care by Idarubicin-loaded Beads - IDASPHERE II

NCT02185768

Liver Cancer

COMPLETED PHASE2

Neoadjuvant and Adjuvant Lenvatinib in HCC Patients Treated by Percutaneous Ablative

NCT05113186

Hepatocellular Carcinoma

ACTIVE_NOT_RECRUITING PHASE2

Neoadjuvant and Adjuvant Nivolumab in HCC Patients Treated by Electroporation

NCT03630640

Hepatocellular Carcinoma

COMPLETED PHASE2

Safety and Tolerability of I.V. Infusion of MB07133 in Patients With Unresectable Hepatocellular Carcinoma

NCT00073736

Hepatocellular Carcinoma

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Carcinoma, Hepatocellular

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

The purpose of this study is to assess efficacy and tolerance of hepatic intra-arterial injection of an emulsion of Idarubicine and Lipiodol for treatment of non-metastatic, unresectable hepatocellular carcinoma on cirrhosis with Child-Pugh A/B7.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

No masking is used. All involved know the identity of the intervention assignment.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment arm

hepatic intra-arterial injection of an emulsion of Idarubicine and Lipiodol

Group Type EXPERIMENTAL

Idarubicin and Lipiodol

Intervention Type DRUG

Hepatic intra-arterial chemotherapy consisting of the hepatic intra-arterial injection Idarubicin, emulsified with Lipiodol

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Idarubicin and Lipiodol

Hepatic intra-arterial chemotherapy consisting of the hepatic intra-arterial injection Idarubicin, emulsified with Lipiodol

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Advanced tumor disease (extrahepatic except pulmonary micronodules \<7mm of tumoral portal vein thrombosis on positron emission tomography are not a contra-indication.)
* Large HCC with liver invasion \>50%
* 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
* Advanced liver disease (Child B8, B9 or C)
* Contra-indication for the MRI (Pacemaker or neurosensorial stimulator or implantable defibrillator, cochlear implant, ferromagnetic foreing body similar to the nervous structure)
* Contra-indication to the injection of the gadolinium-based contrast agents (history of hypersensibility to the gadolinium chelates, meglumine).
* 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)
* Contra-indication to Lipiodol (Hypersensibility, proven hyperthyroidism, tromatic injuries, bleeding or recent bleeding)
* Concomitant disease or uncontrolled severe clinical situation
* Uncontrolled severe infection
* Vascular anatomy makes it impossible to perform hepatic intra-arterial treatments
* Pregnancy (Beta HCG positive) or breastfeeding
* Patient who for psychological, social, family or geographical reasons cannot be followed regularly
* Vulnerable person
* Concomitant participation of the patient in another research involving the human person

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No