Hepatic chemotherapy for unresectable liver cancer
Traitement Des Carcinomes hépatocellulaires Sur Cirrhose Child A/B7 Par Injection Intra-artérielle hépatique d'Une émulsion de Lipiodol et Idarubicine : Etude de Phase II, Monobras, Multicentrique.
This study is testing a new way to deliver chemotherapy directly to liver tumors in patients with advanced liver cancer who can't have surgery, to see if it works better than traditional methods.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 53 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Angers and 3 other locations) |
| Trial ID | NCT03727633 on ClinicalTrials.gov |
What this trial studies
This trial investigates the use of hepatic intra-arterial injection of Idarubicin emulsified with Lipiodol as a treatment for non-metastatic, unresectable hepatocellular carcinoma in patients with cirrhosis classified as Child-Pugh A or B7. The approach aims to deliver chemotherapy directly to the liver tumor without embolization, potentially improving treatment efficacy. Participants will be monitored for response to the treatment based on measurable lesions according to mRECIST criteria.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically-proven hepatocellular carcinoma who are not suitable for surgical resection or other local therapies.
Not a fit: Patients with advanced tumor disease or those who have previously received chemotherapy or radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with unresectable liver cancer, potentially improving survival rates.
How similar studies have performed: While this approach is innovative, similar studies using intra-arterial chemotherapy have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Angers and 3 other locations
- CHU d'Angers — Angers, France (Recruiting)
- CHU de Dijon — Dijon, France (Not_yet_recruiting)
- CHU de Montpellier — Montpellier, France (Recruiting)
- CHU de Nice — Nice, France (Recruiting)
Study contacts
- Principal investigator: Boris GUIU — Montpellier University Hospital
- Study coordinator: Boris GUIU, MD
- Email: b-guiu@chu-montpellier.fr
- Phone: 04 67 33 75 46
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.