NCT04833387进行中（未招募）2 期
PD-1 Antibody as a Sequential Therapy Following Preoperative Chemoradiotherapy for Locally Advanced pMMR/MSS Rectal Cancer: an Open, Multi-center, Phase II Clinical Trial
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pathological complete response
研究概览
简要总结
In this open-label phase II study, patients will be scheduled for neoadjuvant treatment with PD-1 antibody following preoperative Chemoradiotherapy with capecitabine for pMMR/MSS rectal cancer staged as locally advanced (cT3-T4N+/-M0 for rectal cancer). This treatment will be given during the window period until surgical resection of the tumor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients who personally provided written consent for participation in the study
- •Treatment-naive patients with rectal cancer, in whom the inferior margin of the tumor was at a distance of 12 cm or less from the AV before CRT
- •Primary rectal cancer histopathologically confirmed to be adenocarcinoma
- •Clinical stage of T3,and T4 ,N any,M0,before CRT
- •Macroscopic radical resection could be feasible, based on diagnostic imaging before CRT
- •Patients with the ECOG performance status of 0 or 1 at the time of enrollment
- •Patients without distant metastasis on the imaging test before CRT
- •Preoperative biopsy of tumor immunohistochemistry TPS>1% or CPS>1
- •Life expectancy of greater than 2 years
- •No signs of intestinal obstruction; or the obstruction has been relieved after the proximal colostomy operation
- •Hematology: WBC>4000/mm3; PLT>100000/mm3; Hb>10g/dL
- •Liver function: SGOT and SGPT are less than 1.5 times the normal value; bilirubin is less than 1.5mg/dL
- •Renal function: creatinine <1.8mg/dL Others: non-pregnant or breast-feeding women; no other malignant diseases (except for non-melanoma or cervical carcinoma in situ) within 5 years or during the same period; no mental illness that causes the inability to obtain informed consent; no other serious diseases that can shorten the survival time disease.
- •Have not received rectal surgery in the past;
- •Have not received chemotherapy or radiotherapy in the past;
- •Have not received biological treatment in the past;
- •Past endocrine therapy: unlimited.
排除标准
- •Rectal cancer with unstable microsatellite (MSI or dMMR);
- •Preoperative biopsy of tumor immunohistochemistry TPS≤1% or CPS≤1
- •Known history of human immunodeficiency virus (HIV) or chronic hepatitis B or C (high copy viral DNA);
- •Autoimmune diseases;
- •Other active clinical serious infections (>NCI-CTC version 3.0);
- •Patients in clinical phase I;
- •There is evidence that there is distant metastasis before surgery;
- •Cachexia, decompensation of organ function;
- •Have a history of pelvic or abdominal radiotherapy;
- •Multiple primary cancers;
- •Patients who need treatment for seizures (such as steroids or anti-epileptic treatment);
- •Have a known additional malignant tumors within 5 years. Exceptions include basal cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer;
- •Chronic inflammatory bowel disease, intestinal obstruction;
- •Drug abuse and medical, psychological or social conditions may interfere with patients' participation in research or have an impact on the evaluation of research results;
- •Known or suspected to be allergic to the study drug or to any drug given in connection with this test;
- •Any unstable conditions or situations that may endanger patient safety and compliance
研究组 & 干预措施
PD-1 antibody + capecitabine + radiation
Experimental
干预措施: PD-1 antibody (Drug)
结局指标
主要结局
Pathological complete response
时间窗: 1 year
Pathological complete response will be evaluated with American Joint Committee on Cancer (AJCC) Cancer Staging
次要结局
- Relapse-free survival (RFS)(3 years)
- Overall survival (OS)(3 years)
- Clinical complete response (CCR)(1 year)
研究者
Pei-Rong Ding
Professor
Sun Yat-sen University
研究点 (1)
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