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.
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
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
Single group
Gemcitabine-Oxaliplatin Regimen
DrugVascularisation 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.
Hepatic intra arterial chemotherapy
Procedure/SurgeryThe 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.
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.
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University Hospital, Montpellier
Lead sponsor
Federation Francophone de Cancerologie Digestive
Collaborator
