NCT07099794尚未招募2 期

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

Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 个研究点分布在 1 个国家目标入组 90 人开始时间: 2025年8月1日最近更新: 2025年8月1日

干预措施

试验速览

阶段: 2 期
状态: 尚未招募
发起方: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
入组人数: 90
试验地点: 1
主要终点: Progression-free survival

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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;

排除标准

•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;

研究组 & 干预措施

NALIRI+Lenvatinib

Experimental

Liposomal irinotecan+5-FU/LV+Lenvatinib

干预措施: Liposomal irinotecan+5-FU/LV+Lenvatinib (Drug)

NALIRI

Experimental

Liposomal irinotecan+5-FU/LV

干预措施: NALIRI (Drug)

结局指标

主要结局

Progression-free survival

时间窗: 5 years

The time between participant randomization and first recorded disease progression or death from any cause, whichever occurs first.

次要结局

Adverse events(5 years)
Objective Response Rate(5 years)
Disease control rate(5 years)
Overall survival(5 years)

研究者

发起方

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

申办方类型

Other

责任方

Sponsor

研究点 (1)

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