Pemigatinib Combined With Durvalumab for Previously Treated Biliary Tract Carcinoma

Exclusion Criteria

• •1. Patients who have not received standard first-line treatment for advanced biliary tract tumors;
• •2. Pregnant or breastfeeding women, and women of childbearing age with positive pregnancy test results at baseline;
• •3. Patients diagnosed with central nervous system metastasis by CT/MR/PET-CT;
• •4. Patients who have previously received live vaccine administration or other antitumor treatments such as radiotherapy;
• •5. Patients who have participated in or are currently participating in other drug or therapy clinical trials within 4 weeks prior to the first administration of the study medication;
• •6. Patients who have undergone major surgical procedures within 4 weeks prior to the first administration of the study medication or have not recovered from the side effects of such surgery, or patients who have undergone radiotherapy within 2 weeks prior to the first administration of the study medication;
• •7. Patients with any primary immunodeficiency, active autoimmune disease, or history of autoimmune disease, including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, vitiligo, patients with a history of asthma who have completely resolved in childhood and do not require any intervention in adulthood may be included; patients with asthma requiring medical intervention with bronchodilators are excluded;
• •8. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation, and patients currently using immunosuppressants or corticosteroids for immunosuppressive purposes (dosage \>10mg/day prednisone or other equivalent corticosteroids) and still in use within 2 weeks prior to enrollment;
• •9. Patients with other malignancies within the past 5 years, except for cured skin basal cell or squamous cell carcinoma, superficial bladder cancer, early prostate cancer, in situ cervical cancer, or breast cancer;
• •10. Patients who have received hematopoietic growth factors within 1 week prior to the first administration of the study medication, such as granulocyte colony-stimulating factor (G-CSF), erythropoietin, etc.;
• •11. Patients with positive HIV antibodies or syphilis antibodies, and patients with active hepatitis B or C;
• •12. Known allergies to recombinant humanized PD-L1 monoclonal antibody drugs and their components;
• •13. Patients with symptomatic pleural effusion, pericardial effusion, or ascites requiring clinical treatment;
• •14. Patients with severe cardiovascular diseases within the last 12 months, such as clinically significant coronary heart disease, NYHA≥II congestive heart failure, uncontrolled arrhythmias, myocardial infarction;
• •15. Within 6 months prior to the first administration of the study medication, the following conditions have occurred: deep vein thrombosis or pulmonary embolism; myocardial infarction; severe or unstable arrhythmias or angina; percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass grafting; cerebrovascular accident, transient ischemic attack, cerebral embolism.
• •16. Patients who have undergone any type of gastrointestinal surgery, or have upper gastrointestinal obstruction, bleeding, digestive dysfunction, or malabsorption syndrome that may affect the absorption of the study medication;
• •17. Concurrent severe uncontrollable infections or other severe uncontrollable comorbidities, moderate or severe renal impairment;
• •18. Active pulmonary diseases, such as interstitial pneumonia, pneumonia, chronic obstructive pulmonary disease, asthma, or a history of active tuberculosis.
• •19. Abnormal coagulation function (INR\>2.0, PT\>16s), with a tendency to bleed or currently receiving thrombolytic or anticoagulant therapy, prophylactic use of low-dose aspirin, low molecular weight heparin is allowed;
• •20. Significant clinical bleeding symptoms or a clear tendency to bleed within 3 months, such as coughing or expectorating blood ≥2.5ml, history of gastrointestinal bleeding, esophageal and gastric varices with bleeding risk, bleeding gastric ulcers or patients with vasculitis, etc.; if the baseline fecal occult blood test is positive, it can be retested, and if it is still positive after retesting, a gastroscopy is required, and if gastroscopy indicates severe esophageal and gastric varices, the patient may not be enrolled (patients who have undergone gastroscopy within 3 months and excluded such conditions are excluded);
• •21. Known genetic or acquired bleeding and thrombotic tendencies, such as hemophilia, coagulation disorders, thrombocytopenia, etc.;
• •22. History of substance abuse that cannot be quit or history of mental disorders.
• •23. Use of warfarin or any other coumarin derivative anticoagulants within 14 days prior to the first administration of the study medication.
• •24. Other severe, acute, or chronic medical diseases or laboratory abnormalities that the investigator judges may increase the risk associated with participating in the study or may interfere with the interpretation of the study results.
• •25. Patients deemed to have poor compliance by the investigator, or other conditions that make them unsuitable for participating in this trial.