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 @ 2:22 PM
Ignite Modification Date:
2025-12-24 @ 2:22 PM
NCT ID:
NCT03898895
Eligibility Criteria:
Inclusion Criteria:
1. Aged between 18 and 75 years old;
2. Histopathologically confirmed unresectable primary or initial postoperative recurrent BTC without distant metastasis;
3. No previous radiotherapy or systemic therapy;
4. Adequate volume of the uninvolved liver (larger than 700 mL);
5. At least one measurable lesion based on Response Evaluation Criteria in Solid Tumors 1.1 criteria;
6. Eastern Cooperative Oncology Group performance status score of 0 or 1;
7. Adequate hematologic (absolute neutrophil count ≥ 1.5x109/L, hemoglobin concentration ≥ 90g/L, platelet count ≥ 100 x109/L), hepatic (albumin ≥ 28 g/L, total bilirubin \< 1.5 times the upper limit of normal (ULN), alanine aminotransferase and aspartate aminotransferase \< 5×ULN) and renal function (serum creatine \< 1.5×ULN, creatinine clearance rate ≥ 45ml/min);
8. Life expectancy of at least 12 weeks.
Exclusion Criteria:
1. Have acute or chronic active hepatitis B or C, HBV-DNA\>2000IU/ml or 104 copy/ml; HCV-RNA\>103 copy/ml; both HBsAg and HCV antibody are positive. If the related results become lower than above standards after anti-viral treatment, the patients are qualified for enrolment;
2. Have metastasis in extrahepatic distant organs including lung, central nervous system, bone and etc. Or extrahepatic lymph node metastasis beyond abdomen;
3. Have risky bleeding events requiring transfusion, operation or local therapies, continuous medication in the past 3 months;
4. Have thromboembolism in the past 6 months, including myocardial infarction, unstable angina, stroke or transient ischemic attack, pulmonary embolism, deep vein thrombosis;
5. Have taken aspirin (\>325mg/day) or other antiplatelet drugs continuously for 10 days or more within 2 weeks before enrolment;
6. Uncontrollable hypertension, systolic pressure\>140mmHg or diastolic pressure\>90mmHg after best medical care, or history of hypertensive crisis or hypertensive encephalopathy;
7. Symptomatic congestive heart failure (NYHA class II-IV). Symptomatic or badly-controlled arrhythmia. Congenital long QT syndrome or modified QTc\>500ms upon screening;
8. Have active autoimmune diseases that require systemic treatment within 2 years before enrolment;
9. Active tuberculosis, having antituberculosis therapy at present or within 1 year;
10. Have a known history of prior invasive malignancies within 5 years before enrolment;
11. Pregnant or breastfeeding women, or expecting to conceive or father children within the projected duration of the trial;
12. Have other uncontrollable comorbidities;
13. Infection of HIV, known syphilis requiring treatment;
14. Allergic to elements of camrelizumab.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03898895
Study Brief:
Protocol Section:
NCT03898895