A Phase IIb Randomized Clinical Trial of Immune Checkpoint Inhibitor-based Maintenance Therapy in Patients With Advanced Biliary Tract Cancer

Exclusion Criteria

• •1. Patients who have received more than 10 cycles of immune checkpoint inhibitor (ICI) plus Gemcitabine and Cisplatin combination therapy for advanced biliary tract cancer.
• •2. Patients who have been treated for, or have evidence of recurrence or progression of, any malignancy other than biliary tract cancer within the past 3 years.
• •Exceptions: Patients who have been disease-free for ≥3 years after curative treatment, or patients with the following malignancies are not excluded: basal cell carcinoma of the skin, Stage I squamous cell carcinoma of the skin, carcinoma in situ, intramucosal carcinoma, or superficial bladder carcinoma.
• •3. Patients with residual adverse events from prior therapy or surgery that may interfere with the safety evaluation of the investigational product.
• •4. Patients with a history of hypersensitivity to any component of monoclonal antibody products.
• •5. Patients with a history or evidence of active, non-infectious interstitial lung disease (pneumonitis).
• •6. Patients with symptomatic or clinically active brain or leptomeningeal metastases requiring treatment.
• •(Patients with asymptomatic, stable, and untreated brain metastases may be enrolled.)
• •7. Patients who are immunodeficient or are receiving systemic corticosteroids or other immunosuppressive therapy within 7 days prior to the first dose of the investigational product.
• •(Physiologic doses of corticosteroids, such as for acute asthma exacerbation, may be allowed after consultation with the principal investigator.)
• •8. Patients with uncontrolled or significant cardiovascular disease, defined as any of the following:
• •* Myocardial infarction within 180 days prior to randomization
• •* Uncontrolled angina within 180 days prior to randomization
• •* Congestive heart failure classified as New York Heart Association (NYHA) Class III or IV
• •* Uncontrolled hypertension despite appropriate therapy (systolic ≥150 mmHg or diastolic ≥90 mmHg for \>24 hours)
• •* Clinically significant arrhythmia requiring treatment
• •9. Patients with severe chronic infections or active infections, including active or previously known tuberculosis.
• •10. Patients with active autoimmune disease that has required systemic treatment (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within the past 2 years.
• •(Replacement therapy, such as thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency, is not considered systemic treatment.)
• •11. Patients who have received any anticancer therapy other than immune checkpoint inhibitor + Gemcitabine + Cisplatin combination therapy for biliary tract cancer.
• •(Adjuvant chemotherapy completed ≥6 months before study drug initiation is permitted.)
• •12. Patients who have undergone major surgery under general anesthesia within 28 days or minor/local surgery within 14 days before the start of study treatment.
• •(Diagnostic procedures such as laparoscopic biopsy may be allowed upon investigator's discretion.)
• •13. Patients who, in the opinion of the investigator, have any condition, treatment, active or ongoing symptomatic infection, or abnormal laboratory finding that could confound study results, interfere with study participation, or pose undue risk to the patient.
• •14. Patients with a known history of psychiatric disorders or substance abuse that may interfere with compliance to study requirements.
• •15. Patients with a known history of human immunodeficiency virus (HIV-1/2) infection.
• •16. Patients with active hepatitis B (HBsAg-positive and HBV DNA detected) or active hepatitis C (anti-HCV positive with detectable HCV RNA).