A Randomized, Two-cohort, Prospective Phase II Clinical Study of the Second-line Treatment of Advanced Biliary System Tumors With Liposomal Irinotecan (II) Combination Regimen

Inclusion Criteria: * 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 * ECOG PS：0\~1； * Expected survival ≥12 weeks; * Essential organ and hematological function; * Patients need contraception; Exclusion 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); * Any clinically significant gastrointestinal disorder, including bleeding, inflammation, occlusion, or diarrhea \> grade 2; * A thrombotic or embolic event occurred within 6 months prior to the start of the study therapy; * Use of strong CYP3A4/CYP2C19 inducers including rifampicin (and its analogiaries) and hypericum perforatum or strong CYP3A4/CYP2C19 inhibitors and/or strong UGT1A inhibitors within 14 days prior to signing the informed consent; * Known allergy to the study drug; * An uncontrolled infection occurs during screening; * Patients with congenital or acquired imm…