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临床试验/NCT05202314
NCT05202314招募中不适用

Camrelizumab Combined With Neoadjuvant Chemotherapy After Stent Placement Versus Surgery Alone for Left-Sided Obstructive Colonic Cancer

Beijing Chao Yang Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年12月12日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
1
主要终点
Pathological complete remission

研究概览

简要总结

Patients with obstruction are associated with worse oncologic outcomes compared with those having nonobstructive tumors. Conventionally, patients with malignant large bowel obstruction receive emergency surgery, with morbidity rates of 30%-60% and mortality rates of 7-22%, and about two-thirds of such patients end up with a permanent stoma. Self-expanding metallic stents (SEMS) haven been used as a bridge to surgery (to relieve obstruction prior to elective surgery) in patients with potentially resectable colorectal cancer. Several clinical trials demonstrate that SEMS as a bridge to surgery may be superior to emergency surgery considering the short-term outcomes. SEMS is associated with lower morbidity and mortality rate, increased primary anastomosis rate, and decreased stoma creation rate. Although about half of patients can achieve primary anastomosis after stent placement, the primary anastomosis rate is still significantly lower compared with nonobstructing elective surgery. The interval between stent placement and surgery may be not long enough that bowel decompression is insufficient at the time of operation. Furthermore#the long-term oncologic results regarding SEMS as a bridge to surgery are still limited and contradictory. Sabbagh et al. suggest worse overall survival of patients with SEMS insertion compared with emergency surgery, the 5-year cancer-specific mortality was significantly higher in the SEMS group (48% vs 21%, respectively, P=0.02). One interpretation is that tumor cells may disseminate during the procedure of colonic stenting placement. Immunotherapy has proven to be highly effective as first-line treatment of metastatic colorectal cancer (CRC). And immunotherapy also has emerged as a neoadjuvant approach, possibly changing treatment strategy for both primary resectable and metastatic CRC. We hypothesis that, regardless of the MSI state, immunotherapy (Camrelizumab, an anti-PD-1 antibody) combined with chemotherapy after stenting may improve overall survival by eradicating micrometastasis. Moreover, immunotherapy (Camrelizumab, an anti-PD-1 antibody) combined with neoadjuvant chemotherapy prolongs the interval between stent placement and surgery, and the time for bowel decompression is more sufficient, which may increase the success rate of primary anastomosis and decrease risk of stoma formation, and furthermore, improve OS and PFS.

详细描述

We hypothesis that, regardless of the MSI state, immunotherapy combined with immediate chemotherapy after stenting may improve overall survival by eradicating micrometastasis. Moreover, immunotherapy (Camrelizumab, an anti-PD-1 antibody) combined with neoadjuvant chemotherapy prolongs the interval between stent placement and surgery, and the time for bowel decompression is more sufficient, which may increase the success rate of primary anastomosis and decrease risk of stoma formation, and furthermore, improve OS and PFS.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Radiologically proven colonic obstruction of the left colon/upper rectum presumed secondary to a carcinoma
  • Able to give written, informed consent
  • Primary tumor was resectable
  • ECOG score 0 or 1
  • Haemoglobin greater than 100 g/L after transfusion before chemotherapy,
  • White blood cells greater than 3.0×10# /L
  • Platelets greater than 100×10# / L;
  • Glomerular filtration rate greater than 50 mL per minute as calculated by the Wright or Cockroft formula
  • Bilirubin less than 1.5×Upper Limit of Normal(ULN)
  • ALT and AST less than 2.5×ULN

排除标准

  • Distal rectal cancers(equal or less than 10cm from the anal verge)
  • Patients with signs of peritonitis and/or bowel perforation
  • Patients who did not give informed consent
  • Patients who were considered unfit for operative treatment or refuse surgery.
  • Patients with suspected or proven metastatic adenocarcinoma;
  • Patients with unresectable colorectal cancer, or planning for palliative treatment.

研究组 & 干预措施

Immunotherapy group

Experimental

After clinical success of colonic stenting, regardless of the MSI state all patients will receive Immunotherapy (Camrelizumab 200mg) for 2 cycles compined with neoadjuvant chemotherapy with mFOLFOX6 regimen for 3 cycles or CapeOx regimen for 2 cycles. Patients will undergo surgery 2-3 weeks after the last cycle of chemotherapy, type and extent of the surgery will be selected by the surgeon.

干预措施: Immunotherapy (Camrelizumab) (Drug)

结局指标

主要结局

Pathological complete remission

时间窗: 2 weeks after patients received radical operation

No tumor cell found in surgical specimens

次要结局

  • Overall Survival(3 years after operation)
  • Disease Free Survival(3 years after operation)

研究者

发起方
Beijing Chao Yang Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhen Jun Wang

Professor

Beijing Chao Yang Hospital

研究点 (1)

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