Neoadjuvant Capecitabine, Oxaliplatin, Docetaxel and Atezolizumab in Non-metastatic, Resectable Gastric and GE-junction Cancer: The PANDA Trial
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Incidence of adverse events following treatment (safety)
研究概览
简要总结
In this explorative study, patients with resectabel cancer of the stomach or stomach-oesophagealjunction cancer will receive neoadjuvant treatment.
The treatment will be 1 cyle atzolizumab monotherapy, followed by 4 cycle of atezolizumab and capecitabine, oxaliplatin and docetaxel.
详细描述
In this single-centre, open-label, monocenter study, the investigators will enroll 20 patients with resectable cancer of the stomach of GEJunction.
All patients will be treated with 1 cycle of atezolizumab monotherapy, followed by 4 cycles of combinationtherapy of atezolizumab, capecitabine, oxaliplatin and docetaxel, followed by 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed informed consent
- •patients age 18 and older
- •primary resectable, histologically confirmed gastric or GEJ adenocarcinoma
排除标准
- •no signs of distant metastases
- •no active or history of autoimmune disease or immune deficiency
- •no significant cardiovascular disease
- •no major surgical procedure within 4 weeks prior to initiation of study treatment
- •no current treatment with anti-viral therapy or HBV
- •no pregnancy or breastfeeding
- •no history of malignancy within 3 years prior to screening
研究组 & 干预措施
atezolizumab and chemotherapy
1 cycle of atezolizumab followed by 4 cycles atezolizumab, capecitabine, oxaliplatin and docetaxel
干预措施: Capecitabine (Drug)
atezolizumab and chemotherapy
1 cycle of atezolizumab followed by 4 cycles atezolizumab, capecitabine, oxaliplatin and docetaxel
干预措施: Atezolizumab (Drug)
atezolizumab and chemotherapy
1 cycle of atezolizumab followed by 4 cycles atezolizumab, capecitabine, oxaliplatin and docetaxel
干预措施: Oxaliplatin (Drug)
atezolizumab and chemotherapy
1 cycle of atezolizumab followed by 4 cycles atezolizumab, capecitabine, oxaliplatin and docetaxel
干预措施: Docetaxel (Drug)
结局指标
主要结局
Incidence of adverse events following treatment (safety)
时间窗: until 100 days after last patient last study drug treatment
Adverse events will be assessed (according to CTC-AE v4.0) during treatment
次要结局
- pathological tumor regression grade(Within 6 months after last patient inclusion)