NCT03718624Unknown2 期
A Study of Intraperitoneal and Intravenous Paclitaxel Plus Apatinib and S-1 Conversion Therapy for Gastric Cancer With Positive Exfoliative Cancer Cells
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 36
- 主要终点
- R0-resection rate
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of intraperitoneal and intravenous paclitaxel plus apatinib and S-1 in the conversion therapy of gastric cancer with positive exfoliative cancer cells
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Untreated (e.g. chemotherapy, radiotherapy and other antitumor therapy);
- •Age:18 to 70 years old;
- •Man or female (except pregnant and lactating women);
- •Confirmed to gastric adenocarcinoma;
- •Proven gastric cancer of T stage was T3 and T4, and no distant metastasis was observed. The exfoliative cancer cells detection in peritoneal washes was positive;
- •Blood cell count has to meet the following criteria:
- •WBC≥3.5×109/L; ANC≥1.5×109/L; PLT≥100×109/L; HB≥90g/L;
- •Liver/kidney function has to meet the following criteria:
- •ALT and AST≤2.5*ULN TBIL<1.5*ULN； Serum creatinine ≤1.5*ULN;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- •Participants were willing to join in this study, good adherence and written informed consent.
排除标准
- •Patients with other malignant tumors within 5 years;
- •Metastasis was found to be visible to the naked eye;
- •It has serious or uncontrolled heart diseases and infections (Including atrial fibrillation, angina pectoris, cardiac insufficiency, ejection fraction less than 50%, poor-controlled hypertension and so on);
- •History of psychiatric drugs abuse and can't quit or patients with mental disorders;
- •Patients with severe or uncontrollable mental illness;
- •Patients with tendency of gastrointestinal bleeding, including the following: a local active ulcerative lesions, and defecate occult blood (+ +).Has melena and hematemesis in two months;
- •Pregnant or lactating women;
- •It have serious harm to the patient's safety or affect the patients who have completed the research.
- •The researchers think inappropriate.
研究组 & 干预措施
paclitaxel,apatinib and S-1
Experimental
干预措施: apatinib (Drug)
paclitaxel,apatinib and S-1
Experimental
干预措施: paclitaxel (Drug)
paclitaxel,apatinib and S-1
Experimental
干预措施: S-1 (Drug)
结局指标
主要结局
R0-resection rate
时间窗: within 3 weeks after surgery
There was no residual by the microscope
Conversion to negative rate
时间窗: within 3 weeks after surgery
Exfoliative cytology positive gastric cancer conversion to negative rate.
次要结局
- Overall survival (OS)(5years)
- Progression free survival (PFS)(5years)
- Adverse events(5 years)
研究者
Qun Zhao
Principal Investigator
Hebei Medical University
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