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:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Progression-free survival
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
研究点 (1)
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