Inetetamab Plus Chemotherapy ± PD-1/PD-L1 in HER2+ Advanced Biliary Cancer

Exclusion Criteria

• •Known allergy or contraindication to any component of the study drugs;
• •Previous treatment with anti-HER2 therapies;
• •Prior use of immunotherapy;
• •Use of immunosuppressive agents within 14 days before the first dose, except:
• •Intranasal, inhaled, topical steroids, or local injections (e.g., intra-articular) Systemic corticosteroids ≤10 mg/day prednisone or equivalent Steroids for hypersensitivity reactions (e.g., premedication for CT scans)
• •Known active central nervous system metastases or carcinomatous meningitis;
• •Other malignancies within 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell skin cancer;
• •Major surgery or significant trauma within 4 weeks before randomization, or planned major surgery;
• •Severe cardiac disease;
• •Resting dyspnea due to tumor progression or comorbidities, or requiring supplemental oxygen;
• •Neuropathy ≥ Grade I per NCI criteria;
• •Active interstitial lung disease (ILD) or pulmonary disease requiring bronchodilators;
• •History of immunodeficiency;
• •Participation in another drug trial within 4 weeks before screening;
• •Pregnant or breastfeeding women, or women of childbearing potential with a positive pregnancy test at screening; unwillingness to use effective contraception during and for 6 months after the study;
• •Any serious concomitant illness or conditions that may interfere with the planned therapy or render participation unsuitable.