Hepatic Arterial Infusion Pump (HAIP) Combined With Fuquinitinib as Late-line Treatment in Patients With Colorectal Cancer Liver Metastases（CRLM）: A Phase 2 Single-Arm Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- objective response rate
研究概览
简要总结
This study was a phase 2, single-arm, single-center clinical trial in which previously treated patients with unresectable colorectal cancer liver metastases.
详细描述
The aim of this study is to evaluate the safety and efficacy of hepatic arterial infusion pump chemotherapy combined with fruquintinib in later treatment for colorectal cancer liver metastases. All patients received FOLFOXIRI-HAIP chemotherapy and oral fruquintinib. The primary end point was objective response rate (ORR), and the secondary endpoints were disease control rate (DCR), the liver-specific ORR, overall survival (OS), progression-free survival (PFS), liver-specific PFS, and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 75 years;
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2;
- •Prior treatment with chemotherapy based on oxaliplatin, fluorouracil, and irinotecan, with or without EGFR or VEGFR monoclonal antibodies;
- •at least one measurable intrahepatic target lesion according to RECIST V1.1 criteria
- •normal major organ function
排除标准
- •previous treatment with transarterial chemoembolization (TACE) or HAIC;2) prior use of fruquintinib
- •presence of other systemic primary malignancies, excluding colorectal cancer
- •allergy to the study drug;5) Severe dysfunction of major organs (liver, kidney, heart, or lungs)
研究组 & 干预措施
A Phase II Single-Arm Clinical Trial
All patients received FOLFOXIRI-HAIP chemotherapy and oral fruquintinib. All patients received oral fruquintinib at an initial dose of 4 mg once daily from day 1 to day 21 of each 28-day cycle, and FOLFOXIRI-HAIP chemotherapy with Oxaliplatin 85 mg/m² and Leucovorin 400 mg/m² infused via arterial pump over 2 hours on day 1, Irinotecan 150 mg/m² infused via arterial pump over 90 minutes on day 1,and 5-Fluorouracil 2400 mg/m² infused via arterial pump over 46 hours, repeated biweekly until disease progression, patient's refusal, unacceptable toxic effects, or withdrawal of consent.
干预措施: FOLFOXIRI-HAIP+Fuquinitinib (Drug)
结局指标
主要结局
objective response rate
时间窗: The best evaluation of clinical efficacy from the time of the first initiation of treatment until the patient's disease progression to change of treatment or death, assessed up to 100 months.
ORR is defined as the proportion of patients with the best overall response of CR or PR among all participants.
次要结局
- overall progression-free survival (PFS)(From date of the first treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.)
- overall survival (OS)(From date of the first treatment until the date of date of death from any cause,assessed up to 100 months.)
研究者
Meng Qiu
Professor
West China Hospital