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 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 1:14 AM
NCT ID:
NCT03778593
Eligibility Criteria:
Inclusion Criteria:
1. Histologically confirmed BTC (cholangiocarcinoma or gall bladder (GB) cancer) , except ampulla of Vater cancer
2. In the event that the progression of the gemcitabine/cisplatin is experienced during or after discontinuation of the first line treatment for metastatic, locally advanced or relapsed (it may be considered as a first line treatment that recurrence within six months of completion of the adjuvant or neo-adjuvant chemotherapy using gemcitabine/cisplatin)
3. Patient (or legal representative) has completed an approved consent documents that he or she will participate in the test after receiving sufficient information about the clinical trial
4. East clinical oncology group (ECOG) performance status 0-1
5. One or more measurable lesions by RECIST v1.1.
6. Appropriate organ functions; A. Liver: bilirubin ≤ 3 mg/dL, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 x ULN (in cases of liver metastasis, AST or ALT ≤ 5 x ULN) B. Kidney: An estimate of creatine clearance rate according to the Cockcroft-Gault formula (or local institution's standard method) \> 30 mili-liter (mL)/min C. Hemoglobin ≥ 9 g/dL (transfusion allowed), absolute neutrophil count (ANC) ≥ 1500/μL, platelet count ≥ 75,000/μL.
7. Expected life time over 3 months.
8. Over 19 years old.
9. In case of proper bile excretion function
10. Have the will and ability to comply with the clinical trial plan during the study period, including treatment and scheduled visits and examination.
11. For pre-menopausal women and for women less than one year after the onset of menopause, serum or urine pregnancy tests shall be confirmed negative during screening.
12. For men and fertile women, the use of effective contraceptive methods should be agreed (effective contraception should be used for at least 30 days prior to the initial administration of a investigational drug, the trial period, and at least 90 days after the discontinuation of the test participation).
Exclusion Criteria:
1. ≥ 2 of prior chemotherapy for progressive BTC (except for adjuvant/neo-adjuvant chemotherapy with resting of more than six months)
2. Symptomatic or untreated brain metastasis or spinal cord compression metastasis.
3. Previous treatment using Irinotecan or oxaliplatin
4. In case of major surgery within four weeks just before registration, excluding biopsy for diagnosis
5. In case of chemotherapy or radiation therapy was received within three weeks prior to the administration of a test medication
6. Grade 2 or higher peripheral neuropathy
7. Grade 2 or higher toxicities caused by a previous cancer treatment based on NCI-CTCAE v 4.03 other than hair loss
8. A person diagnosed with another malignant tumor within the last five years. Exceptions include basal or squamous cell carcinoma of the skin or intraepithelial neoplasia (bladder, uterine cervical, colorectal, breast)
9. Pregnant or nursing woman
10. If there is a severe or uncontrolled systemic disease, active infection, active bleeding tendency or organ transplantation history (including allo-hematopoietic stem cell transplantation)
11. The following virus infection A. Known positive history for human immunodeficiency virus (Human Immunodeficiency virus, HIV) test or known acquired immunodeficiency syndrome (AIDS) B. Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (positive Hepatitis B surface -Ag (+) or HCV RNA (+) if anti-HCV Ab screening test is positive)
12. If there is a known alcohol or drug abuse
13. In cases of clinically significant (i.e., active) cardiovascular disease: cerebral hemorrhage/brain infarction, myocardial infarction (pre-registration \< 6 months), unstable angina, congestive heart failure (NYHA classification ≥2) or arrhythmia needed drug therapy.
14. In case of a mental state in which it is impossible to understand and provide the consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT03778593
Study Brief:
Protocol Section:
NCT03778593