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

Liposomal Irinotecan (II) and Fluorouracil and Calcium Folinate in Combination With or Without Renvastinib for Second-line Treatment of Advanced Biliary System Tumors: a Randomized, Two-cohort, Prospective Phase II Study

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.

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 immune deficiency (e.g., HIV);
• Have a history of brain metastases or have developed brain metastases;