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 @ 11:11 PM
Ignite Modification Date:
2025-12-24 @ 11:11 PM
NCT ID:
NCT05185869
Eligibility Criteria:
Inclusion Criteria:
1. Male or female of 18 to 75 years old;
2. Subjects are diagnosed with histologically confirmed unresectable advanced or metastatic pancreatic ductal adenocarcinoma with at least one measurable lesion according to the RECIST 1.1 standard (the CT scan length of the tumor lesion \> 10 mm);
3. Subjects are naïve to systemic treatment;
4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
5. Life expectancy ≥12 weeks;
6. Adequate organ performance based on laboratory blood tests;
7. The toxicity of the previous treatment has been restored to ≤1 level (if there is surgery, the wound has completely healed);
8. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation;
9. Normal swallowing function;
10. Willing to consent and signed the informed consent, and able comply with the planned visit, research treatment, laboratory examination and other test procedures.
Exclusion Criteria:
1. Had other active malignant tumors within 5 years before entering the study;
2. Confirmed or suspicious new metastatic lesion in brain;
3. Subjects are allergy to experimental drugs or any excipients;
4. Coagulation disorders (INR\>1.5, APTT\>ULN);
5. Severe pleural effusion or ascites;
6. Severe and uncontrolled medical diseases, acute infections; recent history of major surgery for myocardial infarction (within 3 months);
7. Subjects combined with other anti-tumor drugs;
8. Chronic diarrhea or intestinal obstruction;
9. Pregnant or lactating women; Fertile subjects who are unwilling or unable to take effective contraceptive measures;
10. Subjects in any trial drug treatment;
11. Severe mental disorder;
12. Other situations that investigators considered should be excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05185869
Study Brief:
Protocol Section:
NCT05185869