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 @ 4:55 AM
Ignite Modification Date:
2025-12-25 @ 4:55 AM
NCT ID:
NCT06779318
Eligibility Criteria:
Inclusion Criteria:
1. Histologically confirmed pancreatic cancer (originating from the pancreatic ductal epithelium);
2. Meets one of the following conditions: Pathologically confirmed as moderately differentiated, moderately to poorly differentiated, or poorly differentiated; or pathologic staging as: T3N0M0, T1-3N1-2M0, T4N0-2M0; or one or more surgical margins are R1 resected (R0 resection if no tumor cells are found more than 1mm from the margin, otherwise R1 resection); or involvement of the portal vein and/or superior mesenteric vein resection; or pre-adjuvant chemotherapy CA19-9 \> 90 U/mL; or pre-adjuvant chemotherapy ctDNA testing positive;
3. Completed standard treatment: Received radical resection, postoperative adjuvant therapy (including adjuvant chemotherapy based on gemcitabine or fluorouracil), and radiotherapy (if applicable);
4. Eligible for oral medication;
5. Age ≥18 and ≤75, male or female;
6. ECOG performance status: 0 to 2;
7. Normal function of major organs as per the following criteria within 14 days prior to starting treatment:① Neutrophil count ≥ 1.5×10\^9/L;② Platelet count ≥ 75×10\^9/L;③ Hemoglobin ≥ 9.0 g/dL;④ AST ≤ 2.5×UNL (upper normal limit) (if liver metastasis present, AST ≤ 5×UNL);⑤ ALT ≤ 2.5×UNL (if liver metastasis present, ALT ≤ 5×UNL);⑥ Total bilirubin ≤ 1.5×UNL;⑦ Creatinine clearance (calculated using the Cockcroft-Gault formula) \> 60 mL/min or serum creatinine ≤ 1.5×UNL;
8. Women of childbearing potential must have used reliable contraception within 7 days prior to enrollment and have a negative pregnancy test, and must be willing to use appropriate contraception during the study and for 6 months after the last dose of the investigational drug. For men, they must be surgically sterile or agree to use appropriate contraception during the study and for 3 months after treatment;
9. Expected survival time ≥6 months;
10. Voluntary participation in the study, signed informed consent, and demonstrated good compliance and cooperation during follow-up.
Exclusion Criteria:
1. Pancreatic cancer originating from non-pancreatic ductal epithelium, including pancreatic neuroendocrine tumors, pancreatic acinar cell carcinoma, pancreatoblastoma, and solid-pseudopapillary tumor;
2. Incomplete macroscopic resection (R2 resection);
3. Presence of distant metastasis (including malignant ascites and pleural effusion, peritoneal metastasis) or locally recurrent pancreatic cancer;
4. CA19-9 \> 180 U/mL within 21 days before enrollment;
5. Severe liver dysfunction (AST/ALT \> 3.5 times the upper limit of normal, alkaline phosphatase \> 6 times the upper limit of normal), with liver drainage;
6. Known peripheral neuropathy (CTCAE ≥ Grade 2);
7. Participation in another clinical trial of cytotoxic drugs, targeted therapies, immunotherapies, etc., within the past 4 weeks, or received systemic chemotherapy, radiotherapy, or biological therapy within the past 4 weeks;
8. Concurrent or metachronous cancers with disease-free survival ≥ 5 years (excluding pancreatic cancer), except for cancers that have been cured or can be potentially cured with local excision (e.g., esophageal cancer, gastric cancer, colorectal cancer, cervical cancer, non-melanoma skin cancer, bladder cancer);
9. Factors that significantly affect oral drug absorption, such as difficulty swallowing, chronic diarrhea, or gastrointestinal obstruction; uncontrolled Crohn's disease or ulcerative colitis;
10. Clinically symptomatic serous effusions (including pleural effusion, ascites, pericardial effusion) requiring symptomatic treatment;
11. Pregnant or breastfeeding women; patients of childbearing potential unwilling or unable to take effective contraceptive measures;
12. Known allergy to the investigational drug, the class of the investigational drug, or its components;
13. Need for systemic corticosteroid treatment (except for local steroid pre-treatment);
14. History of interstitial lung disease (including interstitial pneumonia, pulmonary fibrosis, etc.) or CT findings of interstitial lung disease;
15. Active local or systemic infection requiring treatment;
16. Heart failure NYHA classification ≥ II or severe heart disease;
17. Known HIV infection or history of acquired immunodeficiency syndrome (AIDS) or active hepatitis B or C;
18. Toxicity not recovered (CTCAE \> Grade 1) or previous anticancer surgery not fully recovered;
19. Patients deemed unsuitable for this study by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06779318
Study Brief:
Protocol Section:
NCT06779318