NCT05794971招募中3 期
Regorafenib Combined With Irinotecan Drug-Eluting Beads as Third-line Treatment for Colorectal Cancer Liver Metastases: a Multicentre, Randomised Phase 3 Trial (RIDER)
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2023年6月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This study is a multicentre, prospective, randomised trial, aims to evaluate the efficacy and safety of Irinotecan Drug-Eluting Beads combined with regorafenib as the third-line treatment for a patient with colorectal cancer liver metastases. The study is planned to enrolled 126 patients failing first- and second-line standard chemotherapy treatment.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age, of any race or sex, who have histologic or radiologic proof of colorectal cancer to the liver, who are able to give informed consent, will be eligible.
- •Patients failing first- and second-line standard systemic chemotherapy.
- •Patients with at least one measurable liver metastases, with size > 1cm response evaluation criteria in solid tumors (RECIST)
- •Patients with liver dominant disease defined as ≥80% tumor body burden confined to the liver
- •Less than 60% liver tumor replacement
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score of < 2
- •Child-pugh's grade A or B
- •Life expectancy of > 3 months
- •Non-pregnant with an acceptable contraception in premenopausal women.
- •Hematologic function: absolute neutrophil count (ANC) ≥ 1.5 x 109/L, white cell count (WBC) ≥ 3.0 x 109/L, platelets ≥75 x109/L, international normalized ratio (INR) ≤1.
- •Adequate hepatic and renal function: Alanine aminotransferase (ALT) or aspartate aminotransferase ≤2.5×above upper normal range, total bilirubin≤1.5×above upper normal range, Serum creatinine≤1.5×above upper normal range
- •Women of child bearing potential and fertile men are required to use effective contraception negative serum beta human chorionic gonadotropin (βHCG)
- •Signed, written informed consent
排除标准
- •Prior treatment with TACE, regorafenib or fruquintinib
- •Patients with brain metastases
- •With serious heart, kidney, bone marrow, or lung, central nervous system diseases.
- •Patients suffered with other cancer.
- •patients who were seriously ill and had history of chronic disease such as tuberculosis (TB) and human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS) were excluded from the study.
- •known or suspected history of allergy to any of the related drugs used in the study
- •Women who are pregnant or breast feeding
- •Patients with serious somatic or psychiatric illness regarded as contraindications or in need of treatment that would interfere with study participation.
研究组 & 干预措施
Irinotecan Drug-Eluting Beads combined with regorafenib
Experimental
干预措施: Regorafenib and DIBIRI (Drug)
regorafenib
Active Comparator
干预措施: Regorafenib (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: 24 months
OS is defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.
次要结局
- Duration of response (DOR)(24 months)
- Disease Control Rate (DCR)(24 months)
- Progression-Free Survival (PFS)(24 months)
- Objective Response Rate (ORR)(24 months)
- Adverse enents(24 months)
研究者
Yanhong Deng
Director of Medical Oncology, Clinical Professor
Sun Yat-sen University
研究点 (1)
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