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 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 1:04 AM
NCT ID:
NCT06849193
Eligibility Criteria:
Inclusion Criteria:
* 1\. Confirmed by histopathological diagnosis and/or clinical diagnosis (typical imaging features, clinical manifestations, laboratory examination, etc.) as biliary malignancy (Chinese Society of Clinical Oncology (CSCO) Guidelines for Diagnosis and Treatment of Biliary malignancy (2024)); 2. Based on unresectable malignant tumor in the diagnosis of biliary and in patients undergoing chemotherapy with immunosuppressant therapy system; 3. The liver function class for Child - Pugh, A or B; 4. More than 18 years of age, gender not limited; 5. Expected survival time for 3 months or more; 6. ECOG PS score 2 or less; 7. Meet the following laboratory test parameters:
1. Hematological system function: Absolute neutrophil count ≥ 1.0×10⁹/L; platelet count ≥ 50×10⁹/L; hemoglobin ≥ 90 g/L; international normalized ratio less than 1.7 or prothrombin time prolongation not exceeding 4 seconds.
2. Liver function: Alanine aminotransferase/aspartate aminotransferase not exceeding 5 times the upper limit of normal; total bilirubin ≤ 210 μmol/L \[≤ 2.38 mg/dL\]; albumin ≥ 28 g/L.
3. Renal function: Serum creatinine not exceeding 1.5 times the upper limit of normal.
Exclusion Criteria:
* Malignant tumors other than BTC;
* Moderate to severe ascites (ascites reaching a Child-Pugh score of 3);
* Any local treatment (including transcatheter interventional therapy, ablation therapy, internal/external radiotherapy, etc.) or surgical resection or traditional Chinese medicine within 4 weeks before the combination of systemic chemotherapy and immunotherapy;
* Incomplete data, such as incomplete laboratory test data, missing or poor-quality imaging data, or lack of prognostic information;
* Severe liver dysfunction, such as decompensated cirrhosis and other liver diseases that significantly affect bilirubin levels;
* Severe comorbidities, such as refractory hypertension (blood pressure still higher than 150/100 mm Hg after optimal drug treatment), persistent arrhythmia (CTCAE grade 2 or above), any degree of atrial fibrillation, prolonged QTc interval (more than 450 milliseconds in men and more than 470 milliseconds in women), renal insufficiency, etc.;
* Human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome;
* Pregnant or lactating women;
* Acute or chronic mental disorders (including mental disorders that affect the subject's enrollment, treatment intervention, and follow-up).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06849193
Study Brief:
Protocol Section:
NCT06849193