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 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT04216758
Eligibility Criteria:
Inclusion Criteria:
* Signed informed content obtained prior to treatment
* Age ≥18 years and ≤ 80 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Pathologically confirmed after R0 resection of pancreatic adenocarcinoma.
* The expected survival after surgery ≥ 6 months
* No serious blood system, heart, lung function abnormalities and immune defects (refer to the respective standards)
* White blood cell (WBC) ≥ 3 × 109/L; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; Platelets (PLT) ≥ 100 × 109/L; Hemoglobin (Hgb)≥ 9 g/dL
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase \[SGPT\]) ≤ 2.5 × institutional upper limit of normal (ULN); Total bilirubin (TBIL) ≤ ULN; Creatinine (CRE) ≤ 1.5 × ULN
* Prothrombin time (PT) and international normalized ratio (INR) ≤ 1.5 ×ULN
* Baseline (postoperative) abdominal pelvic CT (plain scan + enhancement) and chest CT scan without tumor lesions;
* No serious adverse events (fatal or life-threatening, persistent or significant loss of function or disability, requiring hospitalization or prolonged hospital stay) within 4-12 weeks after surgery;
* Comply with research visit plans and other program requirements.
Exclusion Criteria:
* with other systemic malignancies
* Patients who have received any form of anti-tumor therapy before surgery, including chemotherapy, radiotherapy, interventional chemoembolization, radiofrequency ablation, and molecular targeted therapy
* used any other study drug within 5 weeks prior to enrollment;
* Patients with central nervous system diseases, mental illness, unstable angina pectoris, congestive heart failure, severe arrhythmia and other serious diseases that cannot be controlled
* Uncontrolled infection, hemorrhage, pancreatic leakage, bile leakage, or other postoperative complications during baseline examination; acute and chronic metabolic acidosis (including ketoacidosis, lactic acidosis) failed to be corrected;
* History of allergic reactions attributed to compounds of similar chemical or biological composition to nab-paclitaxel or gemcitabine or tegafur
* Pregnant or nursing women
* Any condition that may compromise patient safety or study data integrity, including serious medical risk factors, medical conditions, and laboratory abnormalities;
* Patients may leave the observation for 7 days or more during the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04216758
Study Brief:
Protocol Section:
NCT04216758