A Single-arm, Single-center Exploratory Clinical Study of Penpulimab Injection Combined With SOX in the Perioperative Treatment of Gastric Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 47
- 主要终点
- Pathological complete response(pCR)
研究概览
简要总结
To explore the efficacy and safety of Penpulimab combined with SOX in the perioperative treatment of gastric cancer
详细描述
Gastric cancer is one of the malignant tumors that seriously threaten human health. It is the sixth most common malignant tumor in the world. According to Global Cancer Statistics 2020, there were about 1.089 million new cases of gastric cancer and 768,000 deaths of gastric cancer worldwide in 2020. Multidisciplinary treatment with radical surgical resection as the core is the mainstream mode of comprehensive treatment of gastric cancer at present, and radical gastrectomy is recognized as the best treatment. However, for patients with advanced gastric cancer, the effect of surgery alone is not good, and the postoperative tumor recurrence rate is high. In order to improve the disease-free survival rate and overall Surv Ival (OS) rate of gastric cancer patients after surgery, perioperative comprehensive therapy has been gradually adopted by the majority of scholars, and has achieved encouraging efficacy in clinical application.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed and dated informed consent;
- •At least 18 years of age;
- •ECOG PS: 0-1;
- •Patients with gastric cancer diagnosed as T3-4NXMX by imaging;
- •Patients with gastric adenocarcinoma diagnosed by cytology;
- •Patients with gastric cancer assessed by the surgeon as suitable for neoadjuvant therapy or conversion therapy followed by radical resection;
- •Laboratory tests should meet the following requirements (28 days before enrollment in baseline period) :
- •Women should agree that they must use contraception during and for 6 months after the study; Had a negative serum pregnancy test within 7 days prior to study enrollment and had to be non-lactating; Men should agree that they must use contraception during the study and for 6 months after the end of the study period.
排除标准
- •Co-existing with other malignant tumors (except cured basal cell carcinoma of the skin);
- •Gastric cancer patients with T1-2N0M0;
- •Previous treatment including anti-PD-1 /PD-L1/CTLA-4 antibody therapy or other immunotherapy directed against PD-1/PD-L1/CTLA-4;
- •Weight loss greater than or equal to 20% within 4 weeks before the first dose;
- •Severe hypersensitivity after administration of other monoclonal antibodies;
- •The presence or history of any active autoimmune disease
- •Immunosuppressive therapy, systemic or absorbable local hormone therapy (dose > 10mg/ day prednisone or other effective hormone) is required to achieve immunosuppression and continues to be used within 2 weeks of the first administration;
- •Patients with multiple factors affecting oral medication
- •Uncontrolled pleural effusion, pericardial effusion, or ascites that require repeated drainage;
- •Had received a prophylactic or attenuated vaccine within 4 weeks before the first dose;
研究组 & 干预措施
SOX and Penpulimab
S-1 ( 40 mg/m2 bid po d1-14) and Penpulimab (200mg ivgtt d1) and Oxaliplatin ( 130 mg/m2 (d1) The treatment period of the above drugs was 3 weeks, and the duration of preoperative treatment was 3 cycles. After treatment, the patient underwent surgery after evaluation. Four cycles of adjuvant therapy with the original regimen (preoperative) were performed after surgery.
干预措施: S-1,Oxaliplatin, Penpulimab (Drug)
结局指标
主要结局
Pathological complete response(pCR)
时间窗: 2 years
the proportion of patients got pathological complete response rate
次要结局
- The 1-year DFS rate(1 years)
- The 1-year OS rate(1 years)
- Disease free survival,DFS(2 years)
- Overall Response Rate (ORR)(2 years)
- tumor regression grade(TRG)(2 years)