This is a single-arm, multicenter clinical study designed to evaluate the efficacy and safety of Iparomlimab and Toripalimab (QL1706) in combination with bevacizumab and chemotherapy as first-line treatment for patients with advanced biliary tract cancer
Informed Consent: Patients voluntarily join this study and sign the informed consent form.
Age: 18 to 75 years old, male or female.
Histologically or cytologically confirmed, unresectable locally advanced or metastatic biliary tract cancer (BTC), including cholangiocarcinoma (intrahepatic and extrahepatic) and gallbladder carcinoma.
No prior systemic anti-tumor therapy for locally advanced or metastatic BTC.
Histologically or cytologically confirmed small cell carcinoma, neuroendocrine tumors, lymphoma, sarcoma, colloid carcinoma, adenosquamous carcinoma, squamous cell carcinoma, mucinous intraductal papillary neoplasm, mucinous cystic neoplasms, or other rare pathological types of biliary tract tumors.
Brain Metastases: History of brain metastases or presence of active brain metastases.
Vascular Invasion & Bleeding Risk: Imaging at screening shows tumor invasion or encasement (>180 degrees) of major blood vessels; or the tumor presents with significant necrosis or cavitation, and the investigator judges that enrollment poses a high risk of bleeding.
Cardiac insufficiency classified as Class II or higher according to the New York Heart Association (NYHA) criteria, or Left Ventricular Ejection Fraction (LVEF) < 50% on echocardiography;
Xianglin Yuan
Lead sponsor
Huazhong University of Science and Technology
Sponsor institution