Phase 2 Trial of Adjuvant Adebrelimab Combined With Capecitabine in High-Risk Resected Cholangiocarcinoma: ACHIEVE

Exclusion Criteria

• •1. Pathological diagnosis of mixed hepatocellular carcinoma and other non-hepatic extra-bile duct cholangiocarcinoma or ampulla of Vater malignant tumor components;
• •2. History of prior systemic treatment;
• •3. History of or concurrent other malignancies, excluding non-melanoma skin cancer, cervical carcinoma in situ, and papillary thyroid carcinoma that have been adequately treated;
• •4. Active tuberculosis infection. Patients with active tuberculosis infection within 1 year prior to enrollment; history of active tuberculosis infection more than 1 year prior to enrollment without proper anti-tuberculosis treatment or tuberculosis is still active;
• •5. History of autoimmune diseases or immunodeficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener\'s granulomatosis, Sjogren\'s syndrome, Guillain-Barre syndrome, or multiple sclerosis;
• •6. Requirement for long-term systemic corticosteroids (dosage equivalent to \>10mg prednisone/day) or any other form of immunosuppressive treatment. Subjects using inhaled or topical corticosteroids may be included;
• •7. Severe cardiopulmonary or renal dysfunction;
• •8. Inadequately controlled arterial hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg) (based on the average of ≥2 blood pressure readings), allowing the achievement of the above parameters through the use of antihypertensive treatment; history of hypertensive crisis or hypertensive encephalopathy;
• •9. Within 3 months prior to enrollment, significant clinical bleeding symptoms or a clear tendency to bleed; abnormal coagulation function (PT \>14s), tendency to bleed, or undergoing thrombolytic or anticoagulant therapy;
• •10. HBV DNA \>2000 IU/ml, active HCV infection (positive HCV antibody and HCV-RNA level above the lower limit of detection);
• •11. Active infection requiring systemic treatment;
• •12. Human immunodeficiency virus (HIV, HIV1/2 antibody) positive;
• •13. History of psychiatric medication abuse, alcoholism, or drug addiction;
• •14. History of allergy to study medication;
• •15. Other factors deemed by the investigator to potentially affect subject safety or trial compliance. Such as severe diseases requiring concurrent treatment (including psychiatric diseases), severe laboratory test abnormalities, or other family or social factors.