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 @ 3:15 PM
Ignite Modification Date:
2025-12-24 @ 3:15 PM
NCT ID:
NCT04289792
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years old and ≤ 70 years old.
* Histologically or cytologically confirmed adenocarcinoma of the pancreas.
* Borderline resectable or locally advanced pancreatic cancer proven by imaging examinations via multidisciplinary approaches according to NCCN guidelines
* No prior chemotherapy or radiotherapy
* ECOG performance status of 0 or 1.
* Without distant metastasis
* The maximum diameter of the tumor must not exceed 5 cm
* Acceptable hematology parameters: a. Absolute neutrophil count (ANC) ≥1500 cell/mm3 b. Platelet count ≥100,000/mm3 c. Hemoglobin (Hgb)≥9 g/dL
* Acceptable blood chemistry levels: a. AST/SGOT and ALT/SGPT≤2.5× upper limit of normal range (ULN) b. Total bilirubin≤1.5 ULN c. Alkaline phosphatase≤2.5× ULN d. Serum albumin\>3 g/dL e. Serum creatinine≤1.5 ULN
* Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
Exclusion Criteria:
* Age \< 18 years old and \> 70 years old. Prior anticancer therapy for pancreatic carcinoma.
* Presence of or history of metastatic pancreatic adenocarcinoma.
* Patients who had surgeries, chemotherapy, or other treatments before inclusion.
* Any other malignancy within 5 years prior to enrollment
* History of allergy or hypersensitivity to nab-paclitaxel or gemcitabine or any of their excipients.
* Peripheral sensory neuropathy Grade \> 1
* Serious medical risk factors involving any of the major organ systems, or serious psychiatric disorders.
* Pregnant or breast feeding.
* Patients enrolled in other clinical trials or incompliant with regular follow-up
* Unwillingness or inability to comply with study procedures.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04289792
Study Brief:
Protocol Section:
NCT04289792