Efficacy and Safety of mFOLFIRINOX as Postoperative Chemotherapy for Pancreatic Cancer in Chinese Patients.

Phase 2 Trial to Investigate the Efficacy and Safety of mFOLFIRINOX as Postoperative Chemotherapy for Pancreatic Cancer in Chinese Patients.

This prospective and open-label study evaluates the efficacy and safety of mFOLFIRINOX as postoperative chemotherapy in treating Chinese patients with pancreatic cancer after R0/R1 resection.

The patients will be treated with systemic FOLFIRINOX chemotherapy of adjusted dosage.

Inclusion Criteria:

1. Patients should be voluntary to the trial and provide with signed informed consent.

2. Histologically confirmed diagnosis of pancreatic cancer

3. Male or female, Age: 18-79 years old.

4. No recurrence or metastasis was observed from a follow-up of 4 to 8 weeks by CT scan after radical surgery.

5. the value of Carbohydrate Antigen19-9(CA19-9) < 180U/mL within 12 weeks after surgery.

6. No previous chemotherapy

7. Eastern Cooperative Oncology Group(ECOG) performance status of 0-1

8. normal function of organ system including the followings.

   • No hematologic dysfunction(Platelets ≥90×10^9/L; Neutrophil ≥2×109/L;Hemoglobin ≥90g/L).
   • Serum bilirubin ≤ 1.2 × upper limits of normal(ULN); aminotransferase ≤ 5 × ULN.
   • Serum creatinine ≤ 1.25× ULN, or creatinine clearance rate(CCR) ≥60mL/min(calculated by Cockcroft-Gault formula).

9. ECOG scored as 0-1.

10. Life expectancy > 3 months.

Exclusion Criteria:

1. Patient is concurrently using other antineoplastic agent.
2. Known severe hypersensitivity to drugs in the regimen.
3. Patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment(with the exception of nonmelanoma skin cancer or cervical carcinoma in situ).
4. Evidence of serious heart disease, including recorded history of congestive heart-failure, uncontrolled serious arrhythmia, angina that needs treatment of drugs, clinical diagnosed cardiac valve disease, history of serious myocardial infarction and intractable hypertension.
5. Evidence of chronic diarrhea(≥4 times/day) or renal dysfunction.
6. Evidence of active infection or active epidemic disease.
7. Psychiatric illness that would prevent the patient from giving informed consent
8. Pregnant or lactating women.