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
Sponsors and collaborators
University Hospital, Montpellier
Lead sponsor
Federation Francophone de Cancerologie Digestive
Collaborator