NCT05052931招募中2 期
Nab-paclitaxel Combined With Oxaliplatin and S-1 for Perioperative Treatment of Advanced Gastric Cancer, a Small-scale, Exploratory Real-world Study
Jianjun Yang1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2021年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- AE
研究概览
简要总结
This is a prospective, single-center, open, historically controlled real-world study.
The aims of this study is to evaluate the safety and effectiveness of Nab-paclitaxel combined with oxaliplatin and S-1 in the treatment of patients with advanced gastric cancer.
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
- •Gastric adenocarcinoma diagnosed by histology.
- •Ambulatory cases, 18-75 years old
- •ECOG performance status ≤ 1
- •Have not received anti-tumor therapy previously (such as surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy)
- •Patients able to tolerate abdominal surgery above grade 3
- •Has adequate organ function as defined by the following criteria:
- •WBC> 4.0×10^9/L
- •ANC> 1.5×10^9/L
- •ANC ≥ 1.5×10^9/L
- •HB ≥ 80 g/L
- •PLT ≥ 100×10^9/L
- •TBIL ≤ 1.5×ULN
- •ALT and AST <2.5 × ULN, for patients with liver metastases, ALT and AST <5 × ULN
- •BUN and Cr ≤ 1.5 × ULN or endogenous creatinine clearance ≥ 50 mL/min
- •No history of other tumors
- •Be willing and able to comply with the plan during the research period
- •Has given written informed consent
- •Life expectancy ≥ 6 months
排除标准
- •Those with a history of other malignancies in the last 5 years, except for cured non-melanoma skin cancer and cervical carcinoma in situ
- •HER-2+ and willing to receive Trastuzumab
- •Pregnancy or breast-feeding women; Men and women who are sexually active (possible to have children) and unwilling to use contraception during the study period
- •Severe, uncontrolled medical diseases and infections; chronic bowel disease or short bowel syndrome
- •Major organ failure, such as compensatory cardiopulmonary liver and kidney failure; severe liver and kidney metabolism abnormalities, affecting the normal metabolism of drugs
- •Patients with other surgical contraindications, such as serious diseases that are difficult to control
- •The researcher believes that patients with a clear gastrointestinal bleeding tendency and/or patients with abnormal blood coagulation function (INR > 1.5)
- •Active HBV or HCV
- •Peripheral neuropathy ≥ Grade 2 according to NCT-CTC AE5.0
- •Patients who are allergic to the drugs in this study, or determined by the investigator as unsuitable to participate in this clinical study
研究组 & 干预措施
treatment group
Experimental
Nab-paclitaxel combined with oxaliplatin and S-1
干预措施: Nab-paclitaxel combined with oxaliplatin and S-1 (Drug)
结局指标
主要结局
AE
时间窗: 2-year
Number of participants with treatment-related adverse events as assessed by NCI-CTCAE V5.0
次要结局
- Disease Control Rate (DCR)(7-month)
- Objective response rate (ORR)(7-month)
- Overall survival (OS)(2-year)
研究者
Jianjun Yang
Director
Xijing Hospital
研究点 (1)
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