NCT07309289招募中3 期
NALIRIFOX Plus Targeted Therapy Versus FOLFOX Plus Targeted Therapy as First-line Treatment for Metastatic Colorectal Cancer: a Multicentre, Open-label, Randomised Trial
Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2025年7月1日最近更新:
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- 18 month PFS rate
研究概览
简要总结
To explore the safety and efficacy of NALIRIFOX plus targeted therapy versus FOLFOX plus targeted therapy as first-line treatment for metastatic colorectal cancer.
详细描述
This is a multicentre, open-label, randomised study to explore the safety and efficacy of NALIRIFOX plus targeted therapy versus FOLFOX plus targeted therapy as first-line treatment for metastatic colorectal cancer.
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
- •≥18 years old
- •Histopathologically confirmed patient with an inoperable metastatic colorectal adenocarcinoma
- •The unresectable stage of metastatic disease has not received any systemic antitumor therapy
- •For subjects previously receiving neoadjuvant or adjuvant therapy, the date of first discovery of disease progression must be at least 12 months removed from the date of last administration of neoadjuvant or adjuvant therapy
- •The presence of at least 1 measurable lesion that can be evaluated according to the RECIST v1.1 criteria
- •ECOG 0~1
- •Normal bone marrow and organ function
- •Understand the situation of this study, patients and/or legal representatives voluntarily agree to participate in this study and sign informed consent form
排除标准
- •Patients with known MSI-H or dMMR who were evaluated by investigators as suitable for treatment with immune checkpoint inhibitors.
- •Patients allergic to the investigational drug and its excipients
- •Underweight (body mass index [BMI]<18.5 kg/m^2
- •Known or suspected central nervous system metastasis
- •Received irinotecan before enrollment
- •Had undergone surgery and other oncologic treatments within the first 4 weeks of enrollment
- •Previous treatment-related toxicity didn't return to NCI-CTCAE v5.0 class I or below.
- •The use of CYP3A, CYP2C8, and UGT1A1 inhibitors or inducers couldn't be discontinued or were not discontinued within 2 weeks prior to enrollment
- •Serious gastrointestinal disorders
- •Interstitial lung disease
- •Tendency of arterial embolism and massive bleeding within 6 months before enrollment (except surgical bleeding)
- •Patients with fluid accumulation that couldn't reach a stable state and small amount of pleural effusion or ascites on imaging without clinical symptoms could be enrolled
- •Intestinal obstruction, or a risk of intestinal obstruction in the short term
- •Gastrointestinal perforation, intraperitoneal abscess, and fistula
- •Any serious or uncontrolled systemic disease, including uncontrolled high blood pressure, heart disease, active bleeding, active viral infection, etc
- •Have had other malignancies within the past 5 years or currently, except cured cervical carcinoma in situ, uterine carcinoma in situ, and non-melanoma skin cancer
- •Patients of childbearing age who refuse to take contraceptives, women who are pregnant or breastfeeding
- •The researchers didn't consider it appropriate to participate in this study
研究组 & 干预措施
NALIRIFOX plus targeted therapy
Experimental
NALIRIFOX plus targeted therapy
干预措施: NALIRIFOX plus targeted therapy (Drug)
FOLFOX plus targeted therapy
Active Comparator
FOLFOX plus targeted therapy
干预措施: FOLFOX plus targeted therapy (Drug)
结局指标
主要结局
18 month PFS rate
时间窗: Eighteen months after the randomization of research participants
To investigate the preliminary antitumor efficacy of study.
次要结局
- Disease control rate(From date of randomization until the date of first documented progression、termination of treatment, or date of death from any cause, whichever came first, assessed up to 12 months)
- Objective response rate(From date of randomization until the date of first documented progression、termination of treatment, or date of death from any cause, whichever came first, assessed up to 12 months)
- Overall survival(From date of randomization until the date of death from any cause, assessed up to 30 months)
- Progression free survival(From date of randomization until the date of first documented progression、termination of treatment, or date of death from any cause, whichever came first, assessed up to 12months)
- R0 resection(From date of randomization until the date of surgical resection, assessed up to 12 months)
研究者
Tianshu Liu
Director
Shanghai Zhongshan Hospital
研究点 (1)
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