mFOLFIRINOX as Adjuvent Chemotherapy in Treating Chinese Pancreatic Cancer Patients

Inclusion Criteria:

• Histologically confirmed adenocarcinoma of the pancreas without distant metastases.

• Receive radical resection of pancreatic cancer

• No prior cytostatic chemotherapy

• Female and male patients > 18 and <=79 years using contraception

• ECOG ≤ 1

• Patient has adequate bone marrow and organ function

• Absolute Neutrophil Count (ANC) ≥ 2.0 x 109/L Platelets ≥ 90 x 109/L Hemoglobin ≥ 90g/L

• Patient has adequate liver function AST and ALT not more than 2.5 times ULN (notmore than 5.0 times ULN if there is liver metastasis) Serum bilirubin ≤ 1.2 x ULNCreatinine ≤ 1.25 times ULN

• Good compliance

• Written informed consent

Exclusion Criteria:

• Pregnant or lactating women

• Distant metastasis.

• Patients with severe gastrointestinal hemorrhage which need frequent bloodtransfusions.

• Refuse to take appropriate contraceptive measures (including male patients).

• Allergic to Oxaliplatin, Irinotecan, Leucovorin or 5-Fluorouracil.

• Severe systemic disease out of control such as unstable or uncompensatedrespiratory, cardiac, liver, renal diseases.

• Patient has a concurrent malignancy or has a malignancy within 5 years of studyenrollment, (with the exception of non-melanoma skin cancer or cervical carcinoma insitu).

• Psychiatric illness that would prevent the patient from giving informed consent.

• Patient is concurrently using other antineoplastic agent

• Patient has used investigational antineoplastic agent within 4 weeks prior to entry.

• Known HIV-positivity.

• No history of chronic diarrhea, nausea or vomit.

• No ≥ grade 2 sensory peripheral neuropathy.

• A history of transmural myocardial infarction (within 6 months prior to entry),congestive heart failure, and unstable angina.

• Infectious disease or inflammation with body temperature ≥ 38 ℃.