Hepatic Arterial Infusion of Gemcitabine-oxaliplatin for Second-line Therapy in Non-metastatic Un… (NCT03364530) | Clinical Trial Compass
RecruitingPhase 2
Hepatic Arterial Infusion of Gemcitabine-oxaliplatin for Second-line Therapy in Non-metastatic Unresectable Intra-hepatic Cholangiocarcinoma
France40 participantsStarted 2018-06-11
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 syst…