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:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-26 @ 11:09 AM
NCT ID:
NCT03662412
Eligibility Criteria:
Inclusion Criteria:
1. patients who have failed second-line chemotherapy: patients who had previously received treatment with gemcitabine-based chemotherapy failed, and received fluorouracil based chemotherapy (such as FOLFIRINOX) and had received or not received radiotherapy and failed treatment.
2. the Eastern Cooperative Oncology Group (ECOG) score is 0-1.
3. subject's informed consent, understanding and willing to cooperate with the test program and sign relevant documents.
Exclusion Criteria:
1. patients with other malignant tumors or pancreatic cancer have unclear clinical diagnosis, or there are some retroperitoneal lesions with other unclear properties.
2. complicated with uncontrollable central nervous system metastases or neoplastic meningitis.
3. complicated with serious and uncontrollable internal diseases such as severe diabetes, severe hypertension, serious infection, congestive heart failure, ventricular fibrillation, coronary heart disease with obvious symptoms or myocardial infarction in the past 6 months.
4. patients with significant renal dysfunction (serum creatinine beyond the normal range).
5. patients with significant abnormal liver function ( serum bilirubin \> 1.5 times or aspartate transaminase (AST)/aspartate transaminase (ALT) \> 2.5 times of the normal upper limit, \> 5 times of the normal upper limit if there is liver metastasis).
6. patients with significantly abnormal white blood cell count (WBC) (neutrophils \< 1500 / mu or platelet \< 100 \* 10 \^ 3 L/mu L or hemoglobin \< 90 g/L).
7. anesthesia, radiotherapy or systemic chemotherapy were performed within the past 2 weeks.
8. drug maintenance: immunosuppressive drugs, and treatment dose of vitamin K antagonist.
9. HIV patients.
10. others: allergic history of similar drugs, pregnancy or lactation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03662412
Study Brief:
Protocol Section:
NCT03662412