Phase 2 study to evaluate safety and efficacy of neoadjuvant treatment of Nivolumab for MSI-H/dMMR locally advanced colorectal cancer

未提供0 个研究点目标入组 30 人开始时间: 2023年4月17日最近更新: 2025年3月12日

试验速览

阶段: 不适用
状态: 暂停
入组人数: 30
主要终点: -

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Single Arm Study
干预模型: Single Assignment
主要目的: Treatment Purpose
盲法: Open(masking Not Used)

入排标准

年龄范围: 18age old over 至 No limit（—）
性别: All

入选标准

•1.The content of this study was fully explained, and written informed consent was obtained from the subject.
•2.Histologically confirmed colorectal adenocarcinoma.
•3.Radical resection is clinically possible without any distant metastases in imaging.
•4.Patients with MSI-H or dMMR.
•5.At least 18 years of age on the date of consent.
•6.ECOG Performance Status is 0-1
•7.No prior treatment for the tumor.
•8.Cases with cT3-4N0M0 or T1-4N1-2M0 based on UICC 8th edition
•9.Patients whose functions of the main organs are adequately maintained.

排除标准

•1.Extensive surgery (excluding colostomy and central venous porting) within 4 weeks before starting protocol therapy.
•2.Complications or history of severe lung disease (such as interstitial pneumonia, pulmonary fibrosis, or severe emphysema).
•3.Colonic stent.
•4.Contraindications for magnetic resonance imaging (MRI), such as cardiac pacemakers.
•5.Serious comorbidities (such as heart failure, renal failure, liver failure, intestinal paralysis, intestinal obstruction, uncontrolled diabetes, and active inflammatory bowel disease).
•6.Active multiple cancers (simultaneous or metachronous multiple cancers with a disease-free interval 5 years or over). However, carcinoma in situ or lesions equivalent to intramucosal carcinoma, which can be cured by local treatment, are not considered active multiple cancers.
•7.Pregnant women, lactating women, positive pregnancy test, or unwillingness to use contraception.
•8.Hepatitis B (HB) antigen positive or Hepatitis C virus (HCV) antibody positive. However, HCV-RNA-negative can be registered.
•9.Positive for human immunodeficiency virus (HIV) infection.
•10.Received live vaccine within 30 days prior to the start of study drug administration.
•11.With complicated autoimmune disease or a history of chronic or recurrent autoimmune disease.
•12.With administration of systemic corticosteroids (except for prophylactic administration for examination or allergic reactions or temporary use to reduce edema associated with radiation therapy) or immunosuppressive agents, or has received such treatment within 14 days prior to enrollment in this study.
•13.With unhealed wounds, ulcers, or fractures.
•14.Unwillingness or inability to comply with the clinical trial protocol.
•15.Other patients that the principal investigator or co-investigator deems ineligible for this study.

结局指标

主要结局

overall response rate

次要结局

Quality of life assessment
Incidence of postoperative adverse events
Incidence of preoperative treatment-related adverse events

研究者

发起方

未提供

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