NCT06477991招募中不适用
The Efficacy of Watch and Wait Strategy or Surgery After Neoadjuvant Immunotherapy for Locally Advanced Colorectal Cancer With dMMR/MSI-H Guided by MRD Dynamic Monitoring(WINDOW): A Single-center, Open-label, Prospective, Phase II Clinical Trial.
Yunnan Cancer Hospital1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2023年10月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Clinical complete response rate with negative MRD
研究概览
简要总结
This study is a single arm, single center, phase II, prospective clinical study aimed at exploring the effectiveness and safety of watch and wait strategy guided by dynamic minimal disease residual (MRD) monitoring to achieve clinical complete response after neoadjuvant immunotherapy for locally advanced colorectal cancer with deficient mismatch repair/ microsatellite instability-high (dMMR/MSI-H).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •( 1 ) Disease characteristics
- •Histologic confirmation for colorectal adenocarcinoma; 2．Immunohistochemical identified as dMMR and/or pCR and/or NGS detection for MSI-H; 3．According to UICC/AJCC TNM staging system (in 2017 version 8) assessment for locally advanced colorectal cancer (II - III, namely cT3-4 and/or N + ）； 4.* clinical staging methods: colon CT staging, approved by pelvic magnetic resonance imaging (MRI) and the rectum rectum cavity ultrasound combined with staging, 5．No signs of intestinal obstruction;Or intestinal obstruction after proximal colon obstruction has been relieved after colostomy surgery; 6．No distant metastasis was confirmed by comprehensive examination (distant organs or (and) the distant lymph node metastasis); ( 2 ) Previous treatment 1．No colorectal cancer surgery before;
- •No previous chemotherapy or radiotherapy ;
- •had not received biological treatment ;
- •Previous endocrine therapy : no restriction.
排除标准
- •1.Immunohistochemistry of tumor biopsy specimens suggested pMMR or microsatellite instability detection suggested MSS ;
- •Chronic hepatitis B or C ( high-copy viral DNA ) with a history of HIV infection or active phase ; 3.Autoimmune diseases ; 4.Other active clinical severe infections ( > NCI-CTC3.0 version ) ;
- •patients with clinical stage I ; 6.Preoperative evidence of distant metastasis ;
- •cachexia, organ dysfunction ;
- •Have a history of pelvic or abdominal radiotherapy ;
- •Patients whose seizures require treatment ( e.g. steroids or antiepileptic treatment ) ; 10.5 years have a history of other malignant tumors, except for cured cervical carcinoma in situ or skin basal cell carcinoma ;
- •Chronic inflammatory bowel disease, intestinal obstruction ;
- •Drug abuse and medical, psychological or social conditions may interfere with patient participation in the study or have an impact on the evaluation of the results of the study ; 13.Known or suspected allergies to the study drug or any drug related to this test ; any unstable condition or condition that may endanger patient safety and compliance ;
结局指标
主要结局
Clinical complete response rate with negative MRD
时间窗: 2023/10/30-2026/10/30
Clinical complete response rate with negative MRD
次要结局
未报告次要终点
研究者
Xuan Zhang
associate senior doctor
Yunnan Cancer Hospital
研究点 (1)
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