To evaluate the efficacy and safety TQB2102 for injection in the treatment of patients with Her2-positive biliary tract cancer.
18 years ≤ age ≤75 years; Eastern Cooperative Oncology Group (ECOG) score 0 to 1;
Subjects must provide sufficient tumor tissue sample and confirm HER2 positivity by central laboratory prior to first dose, defined as immunohistochemistry (IHC) 3+ or IHC 2+ with in situ hybridization (ISH) positive;
The main organs function well;
Biliary tract carcinoma confirmed by histology or cytology;
Have had or are currently suffering from other malignant tumors within 3 years before the first medication;
Unmitigated toxic effects higher than grade 1 of Common Terminology Criteria for Adverse Events (CTCAE) due to any previous treatment;
Major surgical treatment, significant traumatic injury, or long-term unhealed wounds or fractures have been received within 4 weeks prior to initial medication;
Patients with any bleeding or bleeding events ≥CTCAE grade 3 within 4 weeks before the first dose; Aortic/venous thrombosis events, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism, occurred within 6 months prior to initial administration; Treatment with low molecular weight heparin was permitted and antiplatelet drugs were prohibited throughout the study period;
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Lead sponsor