A Phase II Clinical Study of SHR-A1811 in Patients With HER2-expressing/Amplified, Locally Advanced, Unresectable or Metastatic Biliary Tract Cancer (BTC) Who Have Previously Failed First or Second-line Systemic Therapy
This study was to evaluate the efficacy and safety of SHR-A1811 in patients with locally advanced unresectable or recurrent metastatic BTC with HER2 expression / amplification who failed first-line or second-line systemic treatment.
• Age 18-75 years old ( including both ends ), male or female ;
• ECOG-PS score : 0 or 1;
• Expected survival ≥ 12 weeks;
• Subjects with locally advanced or recurrent metastatic biliary tract cancer diagnosed by histopathology or cytology are not suitable for surgical resection, transplantation or ablation;
• Subjects who failed or intolerance after systemic chemotherapies;
• 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 ;
• If the patient has active hepatitis B virus ( HBV ) infection : HBV-DNA must be \< 500 IU / mL；
• Consent to contraception.