NCT06215677进行中（未招募）2 期
Efficacy of Neoadjuvant Immunotherapy for T4 Deficient Mismatch Repair (dMMR) Colon Cancer: A Prospective, Single-arm, Phase Ⅱ Clinical Trial
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）
- 入组人数
- 18
- 试验地点
- 3
- 主要终点
- the rate of R0 resection
研究概览
简要总结
Due to dMMR colon cancer patients respond poorly to conventional chemotherapy, but immunotherapy can significantly improve the pCR in this group of patients, this study intends to explore whether neoadjuvant immunotherapy can improve the R0 resection rate with preservation of adjacent organs in T4 colon cancer patients with dMMR.
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
- •Aged 18-75 years;
- •ECOG score 0-2;
- •Adenocarcinoma confirmed by pathology and dMMR confirmed by IHC or PCR;
- •Tumor located in cecum, ascending colon, transverse colon and sigmoid colon;
- •Patients with clinical stage cT4: (1) Loss of space between tumor and adjacent organs or invasion of adjacent organs as assessed by enhanced CT; (2) R0 resection cannot achieve according to intraoperative exploration;
- •No evidence of distant metastasis;
- •Newly treated patients who have not received treatment including chemotherapy and surgery;
- •Liver, kidney and other organs have good function and can tolerate chemotherapy and surgery;
- •Patients and family members can understand the study protocol, voluntarily participate in the study and sign informed consent.
排除标准
- •A history of other malignant tumors (other than cured basal cell carcinoma, cervical carcinoma in situ, surgically treated localized prostate cancer, or surgically resected breast ductal carcinoma in situ) within the past 5 years;
- •Complicated with intestinal obstruction, intestinal perforation, gastrointestinal bleeding and other patients requiring emergency surgery; pregnant or lactating women;
- •Patients with a history of severe mental illness, immune disease, hormone medication;
- •Patients contraindicated by immunotherapy or surgery;
- •Participated in other clinical researchers in the past 3 months;
- •Any other circumstances that the investigator considers inappropriate for inclusion.
研究组 & 干预措施
Neoadjuvant immunotherapy
Experimental
干预措施: Camrelizumab (Drug)
结局指标
主要结局
the rate of R0 resection
时间窗: Tumour specimen evaluated within 2 weeks after surgery
No tumor infiltration within 1 mm of the surgical margins
次要结局
- Pathological complete response (pCR)(Tumour specimen evaluated within 2 weeks after surgery.)
- diesease-free survival(3 years)
- overall survival(5 years)
- Safety and tolerability of Camrelizumab administered(Up to approximately 9 weeks)
研究者
XIAO Yi, MD
Director, Head of Colorectal surgery, Principal Investigator, Clinical Professor
Peking Union Medical College Hospital
研究点 (3)
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