Biliary tract cancer (BTC) presents with a 5-year survival rate less than 5%. The goal of this clinical trial is to evaluate if Anlotinib plus Nab-Paclitaxels and S-1 as second-line regimen can improve the treatment efficacy in advanced biliary tract cancer (BTC) after progression upon first-line standard treatment, in comparison with standard second-line FOLFOX regimen.
Signed a written informed consent form before enrollment;
Age >18 years, both male and female are eligible;
Patients with pathologically confirmed advanced biliary tract that has progressed after first-line gemcitabine-based therapy;
Have measurable lesions (according to RECIST 1.1 criteria, non-lymph node lesions with a long diameter ≥10 mm on CT scan, or lymph node lesions with a short diameter ≥15 mm on CT scan);
Subjects with a history of or concurrent malignancies, except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix;
Known allergy to macromolecular protein preparations or known hypersensitivity to the components of the administered drugs;
Subjects with existing thyroid dysfunction that cannot be maintained within the normal range by medication;
Uncontrolled hypertension despite optimal treatment, defined as systolic blood pressure >150 mmHg or diastolic blood pressure >90 mmHg;
Sun Yat-sen University
Lead sponsor
CTTQ Pharma
Collaborator