Hepatic Arterial Infusion of Gemcitabine-oxaliplatin for Second-line Therapy in Non-metastatic Unresectable Intra-hepatic Cholangiocarcinoma

NCT03364530 | Recruiting Phase 2 DMC

• 2 other identifiers: RECHMPL17_0025UF 9794
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 7

Brief Summary

We hypothesized that intra-arterial gemcitabine/oxaliplatin administered as second-line treatment could strongly improve objective response rate at 4 months after inclusion in patient with non-metastatic unresectable intra-hepatic cholangiocarcinoma.

Conditions

Cholangiocarcinoma Non-resectable; Non-metastatic

Outcome Measures

Primary Outcomes (1)

• objective response rate

  The primary outcome is to evaluate the objective response rate (complete or partial response) 4 months after inclusion using RECIST 1.1 evaluation.

  4 months after inclusion

Study Arms (1)

Gemcitabine-Oxaliplatin Regimen

OTHER

Drug: Gemcitabine-Oxaliplatin Regimen; Procedure: Hepatic intra arterial chemotherapy

Interventions

Gemcitabine-Oxaliplatin Regimen DRUG

Vascularisation of hepatic tumors is almost exclusively provided by the hepatic artery. Gemcitabine and oxaliplatin have a high rate of hepatic extraction during the first passage, thus allowing the drugs to reach high intra-tumoral concentrations with low systemic toxicity.

Gemcitabine-Oxaliplatin Regimen

Hepatic intra arterial chemotherapy PROCEDURE

The implantation of a hepatic arterial catheter has now been mastered by interventional radiologists and makes it possible to increase the intra-tumoral concentration of the drugs and probably to limit their systemic toxicity. Very recently, we have reported that this combination in progressive IHC following systemic gemcitabine/oxaliplatin has led to partial responses and allowed certain patients to benefit from curative treatment. This suggests that the intra-arterial approach increases the efficacy of these 2 drugs. For locally-advanced IHC, such a loco-regional approach is worth exploring in this poor-prognosis tumor.

Gemcitabine-Oxaliplatin Regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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)

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Federation Francophone de Cancerologie Digestive: collaborator

Study Sites (7)

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, 34295, France

RECRUITING

Hôpital Européen Georges Pompidou

Paris, France

RECRUITING

Institut Gustave Roussy

Villejuif, France

RECRUITING

MeSH Terms

Interventions

gemcitabine-oxaliplatin regimen

Study Officials

• Boris GUIU

  Montpellier University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chloé Guillot

CONTACT

+33467337327; chloe-guillot@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2017
• First Posted: December 6, 2017
• Study Start: June 11, 2018
• Primary Completion: October 21, 2025
• Study Completion (Estimated): October 21, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)