Applicability of CCR Assessment Criteria in PMMR Rectal Cancer Patients Treated with Neoadjuvant Chemoradiotherapy Combined with Immunotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 177
- 试验地点
- 1
- 主要终点
- sensitivity, specificity, accuracy, and AUC
研究概览
简要总结
This study aims to explore how well the usual ways of checking if rectal cancer patients are free of disease signs after treatment work for a new treatment method. The new method combines chemotherapy, radiation, and immune-boosting drugs before surgery. We know these usual ways work for the standard treatment, but we're not sure if they're good enough for this new combo treatment. We'll look at patients with a specific type of rectal cancer that doesn't respond well to just immune-boosting drugs alone. By comparing how patients treated with the new method and the old method respond, we hope to find better ways to tell if the treatment is really working, which could help improve treatment plans for these patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histopathologically confirmed adenocarcinoma;
- •pMMR/MSS tumors;
- •clinical staging of T3-T4 or any lymph node-positive T (N+);
- •no evidence of distant metastasis based on radiological examinations;
- •treatment with long-course chemoradiotherapy (LCRT) with or without immune checkpoint inhibitors (ICI);
- •post-neoadjuvant therapy evaluation with endoscopy and pelvic MRI.
排除标准
- •Presence of other active malignancies;
- •Having severe comorbidities, such as heart failure, severe hepatic or renal insufficiency, etc;
- •Lack of imaging and endoscopic examinations;
- •Treatment plan does not meet the study requirements.
结局指标
主要结局
sensitivity, specificity, accuracy, and AUC
时间窗: January 2025
To evaluate the performance of clinical complete response (cCR) assessment criteria in patients treated with neoadjuvant chemoradiotherapy (nCRT) and neoadjuvant immunochemoradiotherapy (nICRT), we will utilize the area under the curve (AUC), accuracy, sensitivity, and specificity as key performance indicators. These metrics will help us assess the effectiveness of the cCR assessment criteria in both treatment groups.
次要结局
未报告次要终点