Combined Treatment of Treated Bile Duct Cancer

Exclusion Criteria

• •1. subjects with prior or concurrent other malignancies, including combined or mixed hepatocellular/cholangiocarcinoma or potbelly cancer;
• •2. active brain metastases or spinal cord compression;
• •3. not having received systemic antitumor therapy prior to the first study drug treatment
• •4. prior antitumor therapy-related toxicity not recovered to CTCAE ≤ grade 1, except for alopecia and platinum-induced peripheral neuropathy ≤ grade 2
• •5. prior liver transplantation;
• •6. the subject has known prior hypersensitivity to macromolecular protein agents or drug components of sovalteinib
• •7. subject has any active autoimmune disease or history of autoimmune disease (e.g., the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enterocolitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, previous thyroid surgery cannot be included; subject has vitiligo or asthma that has completely resolved in childhood and does not require any intervention in adulthood (subjects with vitiligo or asthma that has been in complete remission in childhood and does not require any intervention as an adult may be included; subjects with asthma requiring medical intervention with bronchodilators are not included);
• •8. subjects who are on immunosuppressive, immunomodulatory, or systemic, or absorbable topical hormone therapy for immunosuppressive purposes (doses \>10 mg/day of prednisone or other equipotent hormone) and who continue to use them within 2 weeks prior to enrollment
• •9. clinically symptomatic ascites or pleural effusion that is not controlled by medication and requires therapeutic puncture or drainage prior to the first study drug therapy;
• •10. have had major surgical procedures or surgical incisions that have not fully healed prior to the first dose of the drug
• •11. patients with clinical cardiac symptoms or disease that are not well controlled, such as (1) NYHA class 2 or higher heart failure (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) patients with clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;
• •12. subjects with active infection or unexplained fever \>38.5 degrees during screening and prior to the first dose (subjects with fever arising from tumors may be enrolled, as determined by the investigator)
• •13. patients with a history of prior and current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, or severely impaired lung function
• •14. live vaccines administered less than 4 weeks prior to study drug administration or likely to be administered during the study period
• •15. subjects with a known history of psychotropic substance abuse, alcoholism, or drug use
• •16. women who are pregnant or breastfeeding;
• •17. are of childbearing potential but unwilling to accept effective contraception
• •18. subjects who, in the opinion of the investigator, should be excluded from this study, for example, subjects who, in the judgment of the investigator, have other factors that might force the study to be terminated mid-study, such as, other serious illnesses (including psychiatric illnesses) requiring comorbid treatment, serious laboratory test abnormalities, accompanying family or social factors that would compromise the safety of the subject, or data and sample collection.