NCT05000554招募中2 期
The Safety and Efficacy of PD-1 Monoantrapical Chemotherapy in the Treatment of Local Advanced Stomach Cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- pCR rate
研究概览
简要总结
To explore the safety and efficacy of local advanced stomach cancer patients receiving new complementary treatment of PD-1 monoantiotherapy before surgery
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
- 否
入选标准
- •Histologically proven adenocarcinoma of the stomach, PD-L1+(CPS≥1).
- •Clinical cT3-4a/N+M0 disease, confirmed by upper gastrointestinal endoscopy and abdominal computed tomography (CT) and laparoscopy.
- •The gastric tumors are macroscopically resectable by distal gastrectomy with D2 lymph node dissection, and R0 or R1 resection can be achieved.
- •No bulky lymph node metastasis is detected by abdominal CT.
- •No pleural effusion, no ascites exceeding the pelvis and no metastasis to the peritoneum, liver or other distant organs are confirmed by abdominal pelvic CT.
- •No clinically apparent distant metastasis.
- •Karnofsky performance status ≥70%.
- •Sufficient oral intake.
- •No previous treatment with chemotherapy or radiation therapy for any tumors.
- •No previous surgery for the present disease.
- •Sufficient organ function, as evaluated by laboratory tests 7 days or more after the date when the anticancer drugs were given. When patients are recovering from myelosuppression,the revised criteria are shown in parentheses. White blood cell count≥3000/mm3 (2000/mm3) Platelet count≥10.0*104/mm3 (5.0*104/mm3) Aspartate aminotransferase≤100 IU/l Alanine aminotransferase≤100 IU/l Total bilirubin≤2.0 mg/dl Serum creatinine≤1.5 mg/dl
- •No need for emergency surgery due to bleeding or perforation of the primary tumor.
- •No mechanical obstruction.
- •Written informed consent.
排除标准
- •Past history of upper abdominal surgery.
- •Past history of surgery for the gastrointestinal tract.
- •Body mass index exceeding 30 kg/m2.
结局指标
主要结局
pCR rate
时间窗: 30 days
Defined as the complete disappearance of tumor cells under a microscope after the completion of the neoadjuvant stomach cancer treatment.
次要结局
- PFS(3 years)
- postoperative complication(Up to 30 days post-operative)
- OS(3 years)
- operative mortality(Up to 30 days post-operative)
- ORR(30 days)
研究者
Quan Wang
Professor
The First Hospital of Jilin University
研究点 (1)
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