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

Launched by YUHONG LI · Jan 8, 2020

Keywords

ClinConnect Summary

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

Gender

ALL

Eligibility criteria

• 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.