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 @ 4:31 AM
Ignite Modification Date:
2025-12-25 @ 4:31 AM
NCT ID:
NCT00965718
Eligibility Criteria:
Inclusion Criteria:
1. Subject who signed the written consent form by themselves, protectors or legal representatives prior to the clinical trial after the person in charge explained fully about objectives, procedure and the characteristics of the study drug.
2. Patient aged 18 to 75
3. Patient with pathologically-confirmed, advanced pancreatic cancer
4. ECOG scale (ECOG-PS) ≤2 (Appendix 4. Performance status scale/score)
5. Patient with anticipated survival period of more than 3 months
6. Patient with progressed disease after Gemcitabine-based primary anti-cancer chemotherapy
7. Patient whose blood test, renal function test and liver function test results meet the following conditions.
Exclusion Criteria:
1. Patient with the medical history of immunodeficiency or autoimmune disease that could be aggravated by immunotherapy (examples: rheumatoid arthritis, systemic lupus erythematosus, vasculitis, multiple sclerosis, adolescent Insulin-Dependent Diabetes Mellitus, etc.)
2. Confirmed immunodeficient patient
3. Patient with the history of cancer other than skin cancer, local prostate cancer or carcinoma in situ of cervix within the last 5 years of the start of study
4. Patient who has received systemic anti-angiogenic agent
5. Patient who has received a chemotherapy other than Gemcitabine based chemotherapy
6. Obvious myocardial failure or uncontrolled arterial hypertension
7. Patient who has experienced serious allergy (judged by the investigator)
8. Patient with serious psychological disease (judged by the investigator)
9. Pregnant woman, breast-feeding woman or woman who want to be pregnant during the trial period
10. Patient who has participated in another clinical trial within the last 4 weeks of the start of study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00965718
Study Brief:
Protocol Section:
NCT00965718