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 @ 7:41 PM
Ignite Modification Date:
2025-12-24 @ 7:41 PM
NCT ID:
NCT06938503
Eligibility Criteria:
Inclusion Criteria:
* 1\. Age 18-75 years old, gender unlimited;
* 2\. Histologically or cytologically confirmed pancreatic cancer;
* 3\. Confirmed as locally advanced pancreatic cancer by CT/MRI imaging, with no evidence of distant metastasis;
* 4\. No prior chemotherapy or other tumor systemic therapy;
* 5\. Measurable disease according to RECIST criteria v1.1;
* 6\. Adequate organ and bone marrow function, defined as follows: hemoglobin≥9.0 g/dL; absolute neutrophil count (ANC)≥1.5×10\^9/L; platelets≥100×10\^9/L; serum total bilirubin (TBIL)≤1.5×ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (ULN); serum creatinine≤1.5×ULN or estimated creatinine clearance \> 60 mL/min;
* 7\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2;
* 8\. Life expectancy is expected to be ≥3 months;
* 9\. Fertile subjects are willing to take contraceptive measures during the study period.
* 10\. Good compliance and signed informed consent voluntarily.
Exclusion Criteria:
* 1\. Refuse chemotherapy or surgery;
* 2\. Other part (e.g. peritoneum, lung, bone, brain) metastasis;
* 3\. History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
* 4\. Accompanied by other serious diseases, including but not limited to: compensatory heart failure (NYHA grade III and IV), unstable angina, poorly controlled arrhythmias, uncontrolled hypertension (SBP\>160mmHg or DBP\>100mmHg); active infections; unmanageable diabetes mellitus; presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage; severe portal hypertension; gastric outlet obstruction; Respiratory insufficiency;
* 5\. Undergone major surgery within 30 days;
* 6\. Participated in other drug related clinical trials within 4 weeks;
* 7\. Known allergy to prescription or any component of the prescription used in this study;
* 8\. With HIV, or active hepatitis (hepatitis B, hepatitis C);
* 9\. Failure to recover from treatment-related toxicity to ≤ grade 1 (adverse events such as alopecia judged by the researcher not to affect the treatment with the research drug are excluded);
* 10.Other reasons that are not suitable to participate in this study according to the researcher's judgment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06938503
Study Brief:
Protocol Section:
NCT06938503