Hepatic arterial infusion of gemcitabine and oxaliplatin for treating non-resectable intra-hepatic cholangiocarcinoma
Hepatic Arterial Infusion of Gemcitabine-oxaliplatin for Second-line Therapy in Non-metastatic Unresectable Intra-hepatic Cholangiocarcinoma: a Multicentric Single-arm Phase II Study
This study is testing a new way to deliver two cancer drugs directly to the liver to see if it helps patients with a specific type of liver cancer that can't be surgically removed.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 7 sites (Amiens and 6 other locations) |
| Trial ID | NCT03364530 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of intra-arterial administration of gemcitabine and oxaliplatin as a second-line treatment for patients with non-metastatic unresectable intra-hepatic cholangiocarcinoma. The approach aims to enhance drug delivery directly to the tumor site, leveraging the unique vascularization of hepatic tumors. The study will evaluate the objective response rate at four months post-treatment, with a focus on minimizing systemic toxicity while maximizing local drug concentration. Previous studies have indicated promising results with this method, suggesting a potential for improved patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically-proven intrahepatic cholangiocarcinoma who have previously undergone first-line systemic therapy and have no extra-hepatic metastasis.
Not a fit: Patients with extra-hepatic metastasis or those whose disease is suitable for curative resection will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve response rates and quality of life for patients with advanced intra-hepatic cholangiocarcinoma.
How similar studies have performed: While hepatic intra-arterial chemotherapy has been rarely used for this condition, preliminary case reports and studies suggest potential efficacy, indicating that this approach is novel yet based on encouraging early findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically-proven intrahepatic cholangiocarcinoma previously treated by first-line systemic therapy * Absence of extra-hepatic metastasis or peritoneal carcinomatosis (as demonstrated by CT-scan) * General health status : World Health Organization Performance Status = 0, 1 * Estimated life expectancy \> 3 months * Disease that is not suitable for resection with a curative intent, as validated by a multidisciplinary committee with at least one senior hepatic surgeon * At least one measurable lesion according to RECIST 1.1 criteria * Platelets ≥100,000/mm3, polynuclear neutrophils ≥ 2000/mm3 , hemoglobin 9g/dL (even transfused patients can be included) * Creatininemia \< 1.5 mol/L * Creatinine clearance \> 30 mL/min * Bilirubinemia ≤2 N (after biliary drainage if necessary) * Aspartate and Alanine Transaminase ≤ 5 mol/L * Reference hepatic MRI (according to the foreseen protocol) done during the 30 days preceding the 1st cycle of treatment * Written informed consent * National health insurance cover Exclusion Criteria: * Patients with cholangiocarcinoma of the gallbladder or common bile duct or those with hepatocholangiocarcinoma or a Klatskin tumor * Patients who are eligible for surgical resection or liver transplantation * Extra-hepatic metastases (Pulmonary micronodules \<7mm without uptake on positron emission tomography are not a contra-indication) * Presence of clinical ascites * History of intra-arterial therapy or more than one line of systemic treatment * Contra-indication or grade 3-4 allergy to any of the treatment drugs Gemcitabine, Oxaliplatin (notably myelosuppression developped before the beginning of the first cycle of therapy, peripheral sensory neuropathy before the first cycle of therapy, severe renal failure) * Grade 2 peripheral neuropathy * Ongoing participation or participation within the 21 days prior to inclusion in the study in another therapeutic trial with an experimental drug * Concomitant systemic treatment with immunotherapy, chemotherapy or hormone therapy * Serious non-stabilized disease, active uncontrolled infection or other serious underlying disorder likely to prevent the patient from receiving the treatment * Pregnancy (beta-human chorionic gonadotropin positive), breast-feeding or the absence of effective contraception for women of child-bearing age * Another cancer in the 5 years preceding or at the time of inclusion in the trial (except for in situ cervical cancer or basal cell carcinoma of the skin) * Allergy or contra-indication to iodine contrast agents (thyrotoxicosis, allergy to the active substance or excipients) * Treatment with anticoagulants (heparin or AVK) that cannot be interrupted for 12 hours * Treatment with anti-platelets that cannot be interrupted for 5 days for aspirin or Plavix. * Contra-indication for use of an intra-arterial approach (severe arteriopathy) * Legal incapacity (persons in custody or under guardianship) * Deprived of liberty Subject (by judicial or administrative decision) * Impossibility to sign the informed consent document or to adhere to the medical follow-up of the trial for geographical, social or psychological reasons * Contraindication for the MRI : Pacemaker or neurosensorial stimulator or implantable defibrillator, cochlear implant, ferromagnetic foreign body similar to the nervous structure.
Where this trial is running
Amiens and 6 other locations
- Amiens University Hospital — Amiens, France (Recruiting)
- Angers University Hospital — Angers, France (Recruiting)
- Bordeaux University Hospital — Bordeaux, France (Recruiting)
- Centre Georges François Leclerc — Dijon, France (Recruiting)
- Uhmontpellier — Montpellier, France (Recruiting)
- Hôpital Européen Georges Pompidou — Paris, France (Recruiting)
- Institut Gustave Roussy — Villejuif, France (Recruiting)
Study contacts
- Principal investigator: Boris GUIU — Montpellier University Hospital
- Study coordinator: Chloé Guillot
- Email: chloe-guillot@chu-montpellier.fr
- Phone: +33467337327
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.