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 @ 5:46 PM
Ignite Modification Date:
2025-12-24 @ 5:46 PM
NCT ID:
NCT03464968
Eligibility Criteria:
Inclusion Criteria:
* 20 years and older
* pathologically confirmed biliary tract cancer (adenocarcinoma) including intrahepatic, extrahepatic, gallbladder, ampulla of vater
* initially inoperable or recurrent
* ECOG 0-2
* as first line chemotherapy, refractory to gemcitabine/cisplatin (at least one cycle applied)
* evaluable or measurable lesion
* within 1 week, patients who meet below laboratory results (hemoglobin \>9.0 g/dL, neutrophil \>1000/uL, platelet\> 75000/uL, serum creatinine \< UNL \* 1.5, AST/ALT \< UNL\*3, total bilirubin \< UNL\*1.5 (available for biliary drainage)
* patients who have ability to understand the purpose, benefit and harm for this trial, and the right to withdraw this trial in any time without any disadvantage
Exclusion Criteria:
* other cancer history
* pregnant or lactating
* uncontrolled medical condition such as infection or cardiovascular disease
* hypersensitivity to experimental drugs
* uncontrolled CNS metastasis, psychologic problem
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT03464968
Study Brief:
Protocol Section:
NCT03464968