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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT04931394
Eligibility Criteria:
Inclusion Criteria:
* Age≥18 years old and ≤80 years old.
* Complete R0 resection for pancreatic cancer with no evidence of malignant ascites, peritoneal metastases or distant metastases.
* Histology confirmed pancreatic adenocarcinoma.
* Eligible histologic variants include adenocarcinoma or variants to include mucinous adenocarcinoma or adenosquamous carcinoma.
* No metastases are found in preoperative examination.
* No prior chemotherapy or radiotherapy.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Life expectancy of greater than 90 days, as judged by the investigator.
* Routine blood test: absolute neutrophil count\>1500/mm3, platelet\>100000/mm3.
* Normal liver function: serum total bilirubin≤2.0mg/dl, aminotransferase (ALT) and aspertate aminotransferase (AST) \<2.5 times of the upper limit of normal value.
* Normal kidney function: serum creatinine\<1.5 times of the upper limit of normal value or creatinine clearance rate\>45ml/min.
* The pancreatic cancer organoid were cultured successfully.
* No severe comorbidities.
Exclusion Criteria:
* Patients with poor condition can not tolerate chemotherapy and targeted therapy.
* Impaired organ functions: heart failure (New York Heart Association III-IV), coronary heart disease, myocardial infarction within 6 months, severe cardiac arrhythmia and respiratory failure.
* Patients diagnosed with other cancer within 5 years.
* Patients who are pregnant or breastfeeding.
* Patients enrolled in other clinical trials or incompliant of regular follow up.
* Patients who did not provide an informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04931394
Study Brief:
Protocol Section:
NCT04931394