Rectal Cancer Neoadjuvant Therapy-Real World Study (RC-NAT-RWS)
2026年4月27日 更新者：Yao Hongwei、Beijing Friendship Hospital
Establishing a Strategy for Selecting Watchful Waiting and Determining the Optimal Timing for Surgery Following Neoadjuvant Therapy
This study aims to utilise a real-world data platform to integrate multi-omics data-including radiomics, gut microbiota, pathological quality control and liquid biopsy-to construct a multidimensional predictive model for the efficacy of rectal cancer treatment following neoadjuvant therapy.
By integrating multimodal data, the study aims to accurately assess the efficacy of neoadjuvant therapy and identify patients suitable for a 'watch-and-wait' strategy, thereby achieving tumour control and preserving organ function without the need for surgery.
Furthermore, it seeks to provide scientific evidence for the efficacy of the 'watch-and-wait' strategy and the selection of optimal timing for surgery, whilst validating the model's effectiveness and assessing its clinical feasibility through prospective clinical trials.
研究概览
详细说明
- Optimisation and predictive modelling of immunotherapy combined with neoadjuvant chemoradiotherapy Through real-world studies, we will evaluate the efficacy and safety of immunotherapy combined with neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer, focusing on comparing outcomes with traditional chemoradiotherapy regimens to optimise neoadjuvant treatment protocols. By integrating radiomics and molecular subtyping data, we will develop a deep learning model to predict the rate of pathological complete response, thereby accurately forecasting treatment outcomes for patients. This model can further optimise personalised treatment decisions, enhance the effectiveness of organ-preservation strategies, and ultimately reduce surgical trauma for patients.
- A Treatment Efficacy Assessment System Combining Multi-omics Data with Artificial Intelligence Integrate multi-omics data (such as molecular subtyping, radiomics, and pathological assessment) with artificial intelligence technology to establish a treatment efficacy assessment system. Utilise deep learning models to analyse pre- and post-treatment imaging data and pathological samples, thereby achieving precise efficacy assessment.
研究类型
观察性的
注册 (估计的)
869
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：hongwei Yao, Professor, Doctoral Degree
- 电话号码：63139203
- 邮箱：yaohongwei@ccmu.edu.cn
学习地点
-
-
Beijing Municipality
-
Beijing、Beijing Municipality、中国、100050
- 招聘中
- Beijing Friendship Hospital
-
接触：
- hongwei Yao
- 邮箱：yaohongwei@ccmu.edu.cn
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
Patients with rectal cancer undergoing neoadjuvant therapy.
描述
Inclusion Criteria:
- The patient is informed and has provided written informed consent;
Rectal adenocarcinoma confirmed by colonoscopic biopsy and pathology, meeting the following criteria:
- Clinical stage II/III locally advanced rectal cancer (LARC): cT1-4aN0-2M0;
- The distal edge of the tumor is ≤ 10 cm from the anal verge (measured by MRI);
- No distant metastasis;
- Scheduled to receive neoadjuvant therapy;
- Age ≥ 18 years, male or female。
Exclusion Criteria:
- Presence of distant organ metastasis;
- Multiple primary colorectal cancers;
- History of prior malignancy (except completely cured carcinoma in situ of the cervix, basal cell carcinoma, or squamous cell carcinoma of the skin).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Neoadjuvant Therapy Cohort for Rectal Cancer
This study is a multicentre, real-world evidence (RWE) study designed to evaluate clinical treatment regimens that offer greater benefits to patients.
It will provide evidence-based guidance for clinicians in China regarding the selection of comprehensive treatment regimens for patients with advanced rectal cancer, thereby further refining and optimising clinical practice guidelines for the diagnosis and treatment of rectal cancer; it will also explore new treatment strategies for patients with locally advanced rectal cancer in the era of immunotherapy.
Study design: A combination of prospective observational and retrospective cohort studies.
The primary endpoint is the complete response rate (pathological complete response and clinical complete response).
|
non-interventional study
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
To compare the complete response rates across different treatments.
大体时间：Post-neoadjuvant Therapy Efficacy Assessment Time Point (within 8-12 weeks after radiotherapy completion)
|
Compare the complete response rates (including pathological complete response [pCR] and clinical complete response [cCR]) between a neoadjuvant regimen combining chemoradiotherapy with immunotherapy and the traditional neoadjuvant chemoradiotherapy regimen, in patients with locally advanced rectal cancer.
|
Post-neoadjuvant Therapy Efficacy Assessment Time Point (within 8-12 weeks after radiotherapy completion)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Safety profile
大体时间：20 weeks after the first radiotherapy session
|
Adverse Events (AEs): Type, incidence, severity, and relationship to the study treatment.
Severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0).
|
20 weeks after the first radiotherapy session
|
|
Therapy Tolerability
大体时间：20 weeks after the first radiotherapy session
|
The proportions of patients with dose interruption, dose reduction, and treatment discontinuation during the neoadjuvant treatment period, all due to treatment-related toxicity.
|
20 weeks after the first radiotherapy session
|
|
Disease-Free Survival (DFS)
大体时间：within 5 years after completion of neoadjuvant therapy
|
Disease-Free Survival (DFS) is a key endpoint (a measure of outcome) used primarily in oncology clinical trials, especially for evaluating adjuvant or curative treatments.
|
within 5 years after completion of neoadjuvant therapy
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall Survival (OS)
大体时间：within 5 years after completion of neoadjuvant therapy
|
Overall Survival (OS) is the primary and most objective endpoint in oncology clinical trials.
It measures the time from a defined starting point (e.g., date of diagnosis, randomization in a trial, or start of treatment) until death from any cause.
|
within 5 years after completion of neoadjuvant therapy
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年1月1日
初级完成 (估计的)
2028年12月31日
研究完成 (估计的)
2028年12月31日
研究注册日期
首次提交
2026年4月20日
首先提交符合 QC 标准的
2026年4月27日
首次发布 (实际的)
2026年5月5日
研究记录更新
最后更新发布 (实际的)
2026年5月5日
上次提交的符合 QC 标准的更新
2026年4月27日
最后验证
2026年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.