NCT03801668Unknown3 期
A Multi-center, Open-label, Randomized Controlled Study of Albumin-bound Paclitaxel Plus S-1 Versus Oxaliplatin Plus S-1 (SOX) as First-line Treatment in Advanced or Recurrent Gastric Adenocarcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 294
- 试验地点
- 1
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
It is a trial to compare the efficacy and safety of Albumin-bound Paclitaxel plus S-1 versus Oxaliplatin plus S-1 (SOX) as first-line treatment in advanced or recurrent gastric adenocarcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age of 18-75 years;
- •Cytological or histological diagnosis of recurrent or metastatic gastric adenocarcinoma;
- •At least one measurable lesion as defined by RECIST 1.1 criteria;
- •ECOG performance status of 0-1;
- •Estimated life expectancy of at least 3 months;
- •Left ventricular ejection fraction (LVEF) ≥ 50%;
- •Bone marrow function: absolute neutrophil count(ANC) ≥1.5×109 /L, platelet count(PLT) ≥90×109 /L, hemoglobin(HB) ≥90 g/L;
- •Liver and kidney function: Creatinine(Cr)≤1.5 x upper limit of normal range(ULN); alanine glutamate transaminase (ALT) and glutamate transaminase (AST) ≤2.5 x upper limit of normal range (ULN), or ≤5 x upper limit of normal range (ULN)when with hepatic metastases，total bilirubin (TBIL)≤1.5 x upper limit of normal range (ULN), or≤2.5 x upper limit of normal range (ULN) when with Gilbert's syndrome;
- •Not be breast-feeding; men and women of reproductive age are willing to take reliable contraceptive measures during the study;
- •Able and willing to comply with the study plans in this protocol and sign the informed consent;
排除标准
- •Have received chemotherapy before；patients that received neoadjuvant or adjuvant chemotherapy are eligible provided the treatment is completed>6 months prior to first recurrence or metastasis;
- •HER-2 positive;
- •Patients with symptomatic brain metastases;
- •II-IV peripheral neuropathy [NCI-CTCAE 4.03];
- •Anti-HCV antibody positive and HCV-RNA positive; anti-HBV antibody positive with active hepatitis ; anti-HIV antibody positive;
- •Patients with serious systemic infection or other diseases;
- •Allergic to the chemotherapy drugs or the materials in this study;
- •Patients with gastrointestinal bleeding that need clinical intervention;
- •Patients with digestive tract obstruction or oral nutrition difficulty;
- •Have a second malignancy within 5 years prior to registration except for cured carcinoma in situ of cervix uteri, non-melanoma skin cancer;
- •Have participated in other clinical trials within 28 days prior to the first dose of this study;
- •Contraindications to chemotherapy;
- •Patients that researcher consider cannot sign informed consent or complete the study plan due to medical science factor, social factor or psychological reasons.
研究组 & 干预措施
Nab-P/S-1
Experimental
Patients in this arm receive chemotherapy with Albumin-bound Paclitaxel plus S-1.
干预措施: Albumin-bound Paclitaxel plus S-1 (Drug)
SOX
Active Comparator
Patients in this arm receive chemotherapy with Oxaliplatin plus S-1.
干预措施: Oxaliplatin plus S-1 (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: up to 3 years
PFS is defined as time from the start of treatment to progression of disease or death.
次要结局
- Overall Response Rate (ORR)(up to 3 years)
- Safety as measured by number and grade of adverse events(up to 3 years)
- Overall survival (OS)(up to 3 years)
研究者
Xianglin Yuan
Professor, Head of the cancer center
Huazhong University of Science and Technology
研究点 (1)
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