A Clinical Study of SHR-A1811 in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer

Inclusion criteria

• Age 18-75 years old (including both ends), male or female;
• ECOG-PS score: 0 or 1;
• Expected survival ≥ 12 weeks;
• Locally advanced or metastatic biliary tract cancer confirmed by histopathology or cytology;
• Subjects who had not previously received any systemic antitumor therapy were allowed to have previously received radical therapy, and had received the last dose of radical therapy for at least 6 months until disease recurrence;
• According to the RECIST v1.1 standard, the subjects had at least one measurable lesion;
• The main organ function is normal, in line with the program requirements;
• Consent to contraception.

Exclusion criteria

• Other active malignancies within 5 years or at the same time;
• Local antitumor therapy was received within 4 weeks prior to initiation of treatment;
• Subjects with biliary obstruction should be excluded;
• There is active autoimmune disease or a history of autoimmune disease that may recur;
• Known or suspected history of interstitial pneumonia or interstitial lung disease, or prior history of interstitial pneumonia or interstitial lung disease requiring hormone therapy;
• Severe infection within 4 weeks prior to initiation of study treatment;
• Active hepatitis B virus (HBV) infection;
• Have serious cardiovascular and cerebrovascular diseases.