Second Line Chemotherapy FOLFIRINOX in Irresectable Cholangiocarcinoma (4CC)

This is an interventional treatment trial for Cholangiocarcinoma focused on measuring Cholangiocarcinoma, FOLFIRINOX, Phase II study Read More

Inclusion Criteria:

• Histological or cytological diagnosis of cholangiocarcinoma.
• Metastatic disease or irresectable locally advanced cholangiocarcinoma.
• Measurable disease according RECIST criteria version 1.1.
• Age from 18 to 75 year.
• WHO/ECOG performance status 0-2.
• Patients who received at least 3 cycles of gemcitabine/cisplatin in the first line.
• Adequate hematological function (WBC > 3.0 x 109/L, platelets > 100 x109/L)
• Adequate hepatic function (bilirubin ≤ 1.5 x upper normal limit (ULN); ALAT or ASAT <5x ULN in case of liver metastases and < 2.5 x ULN in absence of liver metastases.
• Adequate renal function (creatinine clearance > 60 ml/min; creatinine <120 µmol/L)
• Absence of cardiac insufficiency, chest pain (not medically controlled) and myocardial infarction in the 12 months preceding study entry.
• Signed informed consent.

Exclusion Criteria:

• Concurrent secondary malignancies or other malignancies within 3 years prior to enter this study with the exception of non-metastatic basal cell or squamous cell skin cancer or carcinoma in situ of the cervix treated by cone-biopsy or resection
• Presence of cerebral or meningeal metastases
• Contraindication to any of the substances of the planned treatment.
• History of chronic diarrhea or colorectal inflammatory conditions, or of unresolved occlusion or sub-occlusion for which symptomatic treatment is being administered
• Active infection or other serious underlying conditions which may prevent the patient from receiving the planned treatment. For example: prolonged unresolved bacterial cholangitis with destruction of bile duct branches (e.g. after endoprosthesis insertion) or two or more cholangitis in the last 6 months. Patients with other active or uncontrolled severe infection, cirrhosis or chronic active hepatitis will be excluded.
• Presence of cardiac insufficiency, unstable angina pectoris, symptomatic congestive heart, failure myocardial infarction 6 months prior to randomization, serious uncontrolled cardiac arrhythmia.
• Inclusion in another investigational clinical trial
• Women who are pregnant, breast-feeding or not using adequate contraceptive
• Age younger than 18 or older than 76 years
• Individuals under correctional supervision or guardianship