Neo-Sequence 2：Phase 2 Study of Neoadjuvant Chemotherapy Plus Anti-angiogenesis Therapy and Immunotherapy for Locally Advanced Diffuse Gastric Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Pathological response rate
研究概览
简要总结
The regimen of Albumin paclitaxel+SOX+BEV neoadjuvant therapy lasted for 6 cycles, during which PD-1 monoclonal antibody therapy was interspersed for 4 cycles for locally advanced diffuse gastric cancer.
详细描述
The biweekly regimen of Albumin paclitaxel+SOX+BEV neoadjuvant therapy lasted for 6 cycles, during which PD-1 monoclonal antibody therapy was interspersed for 4 cycles. Review CT and gastroscopy every 3 cycles to evaluate the therapeutic effect. Patients who have been evaluated as effective after 6 cycles of treatment may consider surgery; Or continue the dual cycle regimen ofAlbumin paclitaxel+Bevacizumab for 3 cycles, while PD-1 monoclonal antibody for 2 cycles. Afterwards, the therapeutic effect will be evaluated, and surgery, radiotherapy, or maintenance medication treatment will be determined based on the therapeutic effect. Surgical patients begin adjuvant treatment 1-2 months after surgery based on the curative and pathological results of the surgery. Those who fail to evaluate during neoadjuvant therapy will undergo surgery or radiation therapy, or switch to a second-line systemic treatment plan.
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
- •Local advanced diffuse or mixed type gastric cancer detected by pathology and endoscopy;
- •Chest, abdomen, and pelvis enhanced CT, neck and supraclavicular ultrasound, gastroscopy, and endoscopic ultrasound were used to diagnose T3-4NanyM0 gastric cancer or gastroesophageal junction cancer (refer to AJCC staging, 8th edition);
- •Has not received any anti-tumor treatment for gastric cancer yet;
- •Age range from 18 to 75 years old;
- •ECOG score 0-1 points;
- •Liver and kidney function and blood routine meet the following conditions:
- •Neutrophils>1.5G/L, Hb>90g/L, PLT>100G/L; ALT and AST<2.5ULN; TBIL<1.5 ULN; Cr<1.0ULN;
- •Left ventricular ejection fraction>60%;
- •Good compliance and ability to accept long-term follow-up;
- •Sign informed consent.
排除标准
- •Gastrointestinal obstruction or recurrent bleeding cannot be controlled;
- •Those who cannot swallow pills;
- •Diagnose immunodeficiency or active autoimmune diseases, have received or are currently receiving immunomodulators, systemic steroid therapy, or immunosuppressive drugs within the past two years;
- •Interstitial pneumonia;
- •Moderate to severe cirrhosis caused by any reason;
- •Uncontrollable hypertension, severe kidney disease, and significant cardiovascular and cerebrovascular diseases;
- •Active infections that require systemic treatment;
- •Previously suffered from other tumors, excluding cured skin cancer and cervical cancer in situ;
- •Internal medicine diseases that do not meet the chemotherapy criteria at the same time;
- •Pregnant and lactating patients;
- •Individuals with a history of mental illness and poor compliance.
研究组 & 干预措施
Experimental arm
Neoadjuvant Chemotherapy Plus Anti-angiogenesis Therapy and Immunotherapy
干预措施: Albumin paclitaxel+SOX+BEV+ PD-1 monoclonal antibody therapy (Drug)
结局指标
主要结局
Pathological response rate
时间窗: 3 year
No residual cancer cells
次要结局
- OS(3 year)
- R0(3 year)
- EFS(3 year)
- Safety (adverse events) and surgical complications(3 year)