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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Montpellier

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Gemcitabine-Oxaliplatin Regimen
  • Hepatic intra arterial chemotherapy

Treatment groups

40 Participants
are divided into 1 treatment group

Locations

7
Amiens University Hospital Amiens France
Angers University Hospital Angers France
Bordeaux University Hospital Bordeaux France
Centre Georges François Leclerc Dijon France

Sponsors and collaborators

University Hospital, Montpellier

Lead sponsor

Federation Francophone de Cancerologie Digestive

Collaborator