NCT07381322招募中不适用
A Study on the Accurate Evaluation of Pseudoprogression of Rectal Cancer Immunotherapy Based on Multitemporal and Multiparameter MRI
Peiyi Xie2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2026年2月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- The area under curve (AUC) of receive operating characteristic (ROC) curves of models in prediction pseudoprogression after rectal cancer immunotherapy
研究概览
简要总结
This project aims to use multi-temporal, multi-parameter MRI features, blood biomarkers, and clinical indicators to accurately assess pseudoprogression following immunotherapy in rectal cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rectal cancer confirmed by biopsy pathology;
- •Clinical stage II-IV determined by imaging examinations;
- •Decided by the MDT team to receive immunotherapy (monotherapy with PD-1/PD-L1 inhibitors or in combination with CTLA-4 inhibitors), without prior treatment of any other kind;
- •Multiparametric MRI images of the rectum obtained within 2 weeks before immunotherapy, and at 6 and 12 weeks after treatment;
- •Follow-up CT/MRI data available; evaluation conducted according to the iRECEST criteria, or surgical resection performed to obtain postoperative pathological results, which are necessary for assessing the efficacy of immunotherapy and diagnosing pseudoprogression versus true progression;
- •Blood test parameters (IL-8, NLR, LDH, S100) and clinical indicators (KPS score, CEA level, T-stage) measured within 2 weeks before immunotherapy, and at 6 and 12 weeks after treatment;
- •In cases where imaging suggests disease progression, pathological biopsy or surgical pathology results must be available.
- •The overall survival period is more than 3 months, and the patient does not have any other uncontrollable diseases;
- •The patient has been fully informed and has signed the informed consent form.
排除标准
- •The primary tumor lesion has been surgically removed at the time of initial diagnosis;
- •History of other malignant tumors;
- •Unable to sign informed consent or complete the trial due to physical or psychological illness;
- •Pregnant or lactating women;
- •Those who are allergic to gadolinium-containing contrast agents or contraindicated to undergo enhanced MRI examination, or those who are claustrophobic or have other contraindications to MRI examination and cannot undergo MRI examination;
- •History of autoimmune diseases such as inflammatory bowel disease;
- •Treatment interruption due to serious complications related to immunotherapy.
研究组 & 干预措施
one group
one group
结局指标
主要结局
The area under curve (AUC) of receive operating characteristic (ROC) curves of models in prediction pseudoprogression after rectal cancer immunotherapy
时间窗: From date of baseline MRI to date of preoperative MRI
次要结局
- The specificity of models in prediction pseudoprogression(From date of baseline MRI to date of preoperative MRI)
- The sensitivity of models in prediction pseudoprogression(From date of baseline MRI to date of preoperative MRI)
- The positive predictive value of models in prediction pseudoprogression(From date of baseline MRI to date of preoperative MRI)
- The negative predictive value of models in prediction pseudoprogression(From date of baseline MRI to date of preoperative MRI)
- The accuracy of models in prediction pseudoprogression(From date of baseline MRI to date of preoperative MRI)
- Disease-free survival and overall survival(From date of enrollement until the date of first documented progression or date of death from any cause,whichever came first,assessed up to 60 months)
- patients are divided into: iCPD patients are classified as the 'tumor progression group after immunotherapy,' while iCR, iPR, and iSD patients are classified as the 'non-tumor progression group after immunotherapy.(From date of enrollement until the date of first documented progression or date of death from any cause,whichever came first,assessed up to 60 months)
研究者
Peiyi Xie
associate chief physician
Sixth Affiliated Hospital, Sun Yat-sen University
研究点 (2)
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