QL1706 Combined With Lenvatinib and GEMOX as First - Line Treatment for Unresectable Biliary Tract Tumors

Exclusion Criteria

• •1. Cholangiocarcinoma of rare histopathological types confirmed by histology or cytology, such as ampullary cancer, small cell cancer, neuroendocrine tumors, sarcoma, and mucinous cystic tumors.
• •2. Subjects with other malignancies within 5 years before enrollment, except for basal cell carcinoma of the skin or carcinoma in situ of the cervix that has been cured.
• •3. History of leptomeningeal carcinoma, brain metastasis.
• •4. Participation in another interventional clinical study within the past 3 months, or concurrent enrollment in another clinical study, unless it is an observational, non-interventional study or the follow-up period of an interventional study.
• •5. Any disease evidence deemed by the investigator to disqualify the subject, such as uncontrolled hypertension, active bleeding disorder, active infection, active interstitial lung disease, severe chronic gastrointestinal disease related to diarrhea, psychiatric illness, or social condition, or a history of allogeneic organ transplantation.
• •6. Severe cardiovascular disease history: NYHA Class II or above heart failure, unstable angina, myocardial infarction, uncontrolled arrhythmia, or cerebrovascular accident within 12 months before drug administration; echocardiogram showing LVEF \<50%; QTc \>480ms (Fridericia method, average of three consecutive measurements 2 minutes apart if QTc is abnormal); poorly controlled hypertension (systolic BP ≥150 mmHg and/or diastolic BP ≥100 mmHg, based on the average of ≥2 measurements); history of hypertensive crisis or encephalopathy.
• •7. Active autoimmune disease within the past 2 years or a history of autoimmune disease that may recur, including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, colitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (excluding patients controlled by hormone replacement therapy).
• •8. Previous immunotherapy, including immune checkpoint inhibitors (e.g., anti-PD-1/L1, CTLA-4, TIGIT, LAG3 antibodies), immune checkpoint agonists (e.g., CD40, CD137, OX40 antibodies), or other immunotherapy for tumor immune mechanisms, except therapeutic antitumor vaccines.
• •9. Co-infection with HBV (HBsAg and/or anti-HBcAb positive with detectable HBV DNA) and HCV (anti-HCV antibody positive), or HBV and HDV (anti-HDV antibody positive).
• •10. Severe peptic ulcer, gastritis, gastrointestinal perforation, abdominal fistula, obstruction, intra-abdominal abscess, or acute gastrointestinal hemorrhage within 6 months before first dose; acute exacerbation of COPD within 1 month before first dose.
• •11. Life-threatening bleeding event within 3 months before first study drug administration, including those requiring transfusion, surgery, local treatment, or ongoing medication.
• •12. Major surgery or severe trauma within 30 days before first dose, or planned major surgery within 30 days after first dose (investigator's decision); minor local surgery within 3 days before first dose (excluding central venous catheter placement and venous port implantation).
• •13. Pregnant or breastfeeding women; men or women of reproductive potential unwilling to use effective contraception from screening until 90 days after last study intervention dose or 180 days after last investigational drug dose.
• •14. Known allergy or hypersensitivity to any study intervention or its excipients.
• •15. Other patients deemed unsuitable for inclusion by the treating physician.