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 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 12:00 AM
NCT ID:
NCT02440958
Eligibility Criteria:
Inclusion Criteria:
* Pathologically confirmed pancreatic ductal adenocarcinoma (metastatic or locally advanced stage)
* Refractory or progress to Gemcitabine based 1st line chemotherapy
* Older than 19 years old and younger than 75 years old
* Life expectancy\> 3 months
* ECOG Performance status ≤2
* Only patients with measurable lesions in imaging study
* Adequete BM function (WBC ≥ 3,500/µl, absolute neutrophil cell count ≥ 1,500 /µl, platelet count ≥ 100,000/µl)
* Adequete liver function (total bilirubin \< 1.5 X the upper limits of normal (ULN), AST and ALT \<3 X UNL, and alkaline phosphatases \< 3 X ULN or \< 5 x ULN in case of liver involvement)
* Adequete renal function (serum creatinine \< 1.5 mg/dl)
* Adequete cardiopulmonary function
Exclusion Criteria:
* Pathologically confirmed another type of pancreatic cancer (except ductal adenocarcinoma)
* Metastatic adenocarcinoma of originating at other organs
* Evidence with CNS metastasis
* Active infection
* Uncontrolled serious medical or psychiatric illness which can induce toxicity ro complication of treatment, such as inability to swallow, lacking physical integrity of the gastrointestinal tract, malabsorption syndrome, or active ulceration at upper gastrointestinal tract.
* Coexisting of other malignancies within 5 years, except squamous cell carcinoma and basal cell carcinoma of the skin
* Participation in any other investigational drug study within 1 month
* No signed informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
75 Years
Study:
NCT02440958
Study Brief:
Protocol Section:
NCT02440958