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

Sponsors and collaborators

University Hospital, Montpellier

Lead sponsor

Federation Francophone de Cancerologie Digestive

Collaborator