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 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT06389760
Eligibility Criteria:
Inclusion Criteria:
* 1\. Age 18 years or older, gender unlimited;
* 2\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
* 3\. Had undergone complete macroscopic resection for pancreatic cancer (R0 or R1 resection) with histological confirmation and with no evidence of distant metastasis as demonstrated by imaging;
* 4\. No prior tumor therapy;
* 5\. Adequate organ and bone marrow function, defined as follows: White blood cells (WBC) ≥ 3.0×10\^9/L; absolute neutrophil count (ANC)≥1.5×10\^9/L; hemoglobin≥9.0 g/dL; platelets≥75×10\^9/L; serum total bilirubin (TBIL)≤1.5×ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (ULN); serum creatinine≤1×ULN or estimated creatinine clearance ≥ 50 mL/min;
* 6\. Left ventricular ejection fraction (LVEF) ≥ 50%;
* 7\. Fertile subjects are willing to take contraceptive measures during the study period.
* 8\. good compliance and signed informed consent voluntarily
Exclusion Criteria:
* 1\. Prior systemic anti-tumor therapy, such as chemotherapy, radiotherapy;
* 2\. Participated in other drug clinical trials within 4 weeks;
* 3\. History of other malignancies;
* 4\. Immunodeficiency, or other immune-related disorders requiring medical intervention;
* 5\. Postoperative complications such as bleeding;
* 6\. Woman who are pregnant or breastfeeding;
* 7\. Drug abuse, or clinical, psychological or social factors that may have an impact on informed consent or the implementation of the study;
* 8.Known allergy to prescription or any component of the prescription used in this study, including nimotuzumab, oxaliplatin, irinotecan, fluorouracil, gemcitabine, and capecitabine.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06389760
Study Brief:
Protocol Section:
NCT06389760