Last updated: February 13, 2023
Sponsor: Yuhong Li
Overall Status: Completed
Phase
2
Condition
Digestive System Neoplasms
Treatment
N/AClinical Study ID
NCT04224402
FOLFIRINOX-PC-Adjuvant
Ages 18-79 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients should be voluntary to the trial and provide with signed informed consent.
- Histologically confirmed diagnosis of pancreatic cancer
- Male or female, Age: 18-79 years old.
- No recurrence or metastasis was observed from a follow-up of 4 to 8 weeks by CT scanafter radical surgery.
- the value of Carbohydrate Antigen19-9(CA19-9) < 180U/mL within 12 weeks after surgery.
- No previous chemotherapy
- Eastern Cooperative Oncology Group(ECOG) performance status of 0-1
- 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).
- ECOG scored as 0-1.
- Life expectancy > 3 months.
Exclusion
Exclusion Criteria:
- Patient is concurrently using other antineoplastic agent.
- Known severe hypersensitivity to drugs in the regimen.
- Patient has a concurrent malignancy or has a malignancy within 5 years of studyenrollment(with the exception of nonmelanoma skin cancer or cervical carcinoma insitu).
- Evidence of serious heart disease, including recorded history of congestiveheart-failure, uncontrolled serious arrhythmia, angina that needs treatment of drugs,clinical diagnosed cardiac valve disease, history of serious myocardial infarction andintractable hypertension.
- Evidence of chronic diarrhea(≥4 times/day) or renal dysfunction.
- Evidence of active infection or active epidemic disease.
- Psychiatric illness that would prevent the patient from giving informed consent
- Pregnant or lactating women.
Study Design
Total Participants: 80
Study Start date:
January 31, 2020
Estimated Completion Date:
December 31, 2022
Study Description
Connect with a study center
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong 510060
ChinaSite Not Available

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