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:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
NCT ID:
NCT03882866
Eligibility Criteria:
Inclusion Criteria:
* Age: 18-80 years
* Cytologically or histologically confirmed pancreatic adenocarcinoma
* Inoperable locally advanced pancreatic cancer based on American Joint Committee on Cancer (AJCC) staging system (8th ed) (without distant metastasis)
* Single tumor size≤ 6 cm
* Karnofsky performance score （KPS）≥60
* Estimated survival ≥3 months
* Without other several comorbidity
* Participants must have adequate organ function:
* WBC≥3×109/L; HGB≥90g/dL; PLT≥50×109/L
* Aspartate Transaminase (AST)/alanine aminotransferase ( ALT) ≤3 × institutional upper limit of normal
* Albumin≥3g/dL
* Total bilirubin ≤3mg/dL
* PT≤3 × institutional upper limit of normal or INR≤2.3
* Creatinine ≤1.5 × institutional upper limit of normal
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Patients with other malignant tumors
* History of other anti-cancer therapy, including surgery,radiation, ablation and so on
* Pregnant or lactating women
* Patients with Immunodeficiency disease
* Several heart disease, for example: New York Heart Association (NYHA) class III/IV congestive heart failure，active coronary heart disease and severe arrhythmia
* Uncontrolled hypertension
* Ongoing or active infection (\>grade 2 based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) 4.0 edition)
* Active tuberculosis
* Chronic renal insufficiency
* Other organ failure
* History of organ transplantation
* History of severe mental illness
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03882866
Study Brief:
Protocol Section:
NCT03882866