Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT04224402
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT04224402
Study Brief:
Protocol Section:
NCT04224402