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 @ 12:41 PM
Ignite Modification Date:
2025-12-24 @ 12:41 PM
NCT ID:
NCT03815461
Eligibility Criteria:
Inclusion Criteria:
* patient compliance is good, the research process of this study can be understood, and written informed consent is signed;
* Age ≥ 18 years old, ≤ 75 years old;
* Histologically or cytologically confirmed pancreatic adenocarcinoma；
* no prior treatment;
* Based on imaging findings, MDT decided patients intoborderline resectable (group A) or unresectable (group B) (according to the resectability assessment criteria in the 2018 Pancreatic Cancer Comprehensive Care Guidelines);
* ECOG\<2;
* Bone marrow function: hemoglobin (HGB) ≥ 90g / L; absolute neutrophil count (ANC) ≥ 1.5 × 109 / L; platelets (PLT) ≥ 100 × 109 / L;
* Liver function: ALT, AST ≤ 2.5 × upper limit of normal (ULN), if there is liver metastasis, ALT, AST ≤ 5 × ULN; serum total bilirubin \< 1.5 × ULN;
* Renal function: serum creatinine is within normal range;
* Patients without biliary obstruction, patients requiring biliary stent implantation must be completed at least 7 days prior to enrollment;
* Non-pregnant and lactating women, women of reproductive age/male should take effective contraceptive measures during the study period and within 6 months after the end of the study treatment;
* No contraindication to the use of S-1and albumin-bound paclitaxel.
Exclusion Criteria:
* Patients who have had other malignant tumors within 5 years (except for cured cervical cancer in situ or non-melanoma skin cancer);
* Interstitial pneumonia or pulmonary fibrosis;
* Severe pleural effusion or ascites;
* Watery diarrhea;
* There are serious concomitant diseases: such as HIV-positive,chronic HBV/HCV in active period, people who have diabetes and poorly controlled by hypoglycemic drugs, clinically severe (ie, active) heart disease, uncontrolled epilepsy, central nervous system disease or mental disorder;
* Current or previous patients with grade II peripheral neuropathy;
* Abnormal digestive tract or metabolic function, which may affect the s-1 absorber;
* Participated in other clinical researchers within 4 weeks prior to enrollment;
* Patients who have undergone organ transplantation;
* Patients considered by the investigator to be unfit for this trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03815461
Study Brief:
Protocol Section:
NCT03815461