This is a randomized, two-cohort, multicenter Phase II clinical study. To evaluate the efficacy and safety of liposomal irinotecan II and 5-FU/LV combined with or without renvastinib in the treatment of patients with advanced biliary system tumors, 90 patients were scheduled to be enrolled.
The patients voluntarily joined the study and signed the informed consent;
Histologically or cell line confirmed advanced biliary system malignancies, including intrahepatic, extrahepatic, and gallbladder cancers;
Previous first-line combination therapy failed;
At least one measurable lesion meets the RECIST v1.1 criteria
The patient had previously received irinotecan, 5-Fu, and antiangiogenic agents;
Patients had active malignancies other than BTC within 5 years or at the same time.
Clinical symptoms or diseases of the heart that are not well controlled;
Patients with hypertension who cannot be reduced to the normal range by antihypertensive medication (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg);