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 @ 10:54 PM
Ignite Modification Date:
2025-12-24 @ 10:54 PM
NCT ID:
NCT01317069
Eligibility Criteria:
Inclusion Criteria:
* The patients with gallbladder and bile duct cancer diagnosis by surgical exploration, or intraoperative frozen biopsy (Annex 2).
* Aged 18 to 70 years old, male or female, body condition score generally ECOG 0～2, expected survival ≥ 3 months.
* Subjects were no major organ dysfunction, blood, liver, kidney and heart function was normal, the specific requirements of laboratory indicators:
Blood: WBC count \> 3.0 × 109 / L, Platelet count\> 100 × 109 / L, Hb \> 8.0g/dl. Liver function：serum bilirubin less than 1.5 times the upper limit of normal; ALT and AST less than 3 times the upper limit of normal.
Renal function: creatinine less than 1.5 times the upper limit of normal.
* Participants have used other chemotherapy drugs, subject to the 30-day washout period before proceeding with the test.
* Patients had no anaphylactic reaction with oxaliplatin and fluorouracil in the past.
* Patients who can understand the circumstances of this study and signed informed consent.
Exclusion Criteria:
* Currently is receiving effective treatment；
* Pregnancy, breast-feeding patients；
* Primary brain tumors or central nervous system metastatic tumor is not controlled;
* Patients received chemotherapy, radiotherapy, biological therapy, other drugs or instrument therapy 30 days before enrollment.
* Patients with purulent and chronic infected wounds which delayed healing.
* Patients with liver, kidney and heart failure and coronary heart disease, angina, myocardial infarction, arrhythmia, cerebral thrombosis, stroke and other serious cardiovascular and cerebrovascular disease;
* Patients has a history of mental illness and difficult to control;
* Patients who was considered inappropriate to participate in the trials by the researchers.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01317069
Study Brief:
Protocol Section:
NCT01317069