Clinical Study of Endostar Injection Concomitant With SOX Protocols to Treat Advanced Gastric Cancer
A Randomized, Open and Control Clinical Study of Endostar Injection Concomitant With SOX Protocols in Treating Advanced Gastric Cancer
研究概览
详细说明
Multiple pre-clinical studies have indicated that in dozens of animal tumor models and human tumor-metastatic mice tumor models, the effective rate of Endostar was 47%～91% in daily dosage of 10～100mg/kg, and covered human commonly seen malignant tumors, such as lung cancer, gastric cancer, breast cancer, colorectal cancer, hepatic cancer, malignant melanoma and non-Hodgkin's lymphoma, etc.. The development and progression of gastric cancer was in association with angiogenesis. An animal research observed the influence of Endostar on tumor strains in nude mice with gastric cancer, and the results showed that tumor size shrunk rapidly and the expressions of VEGF, bFGF, VEGF-C, VEGFR-3, bcl-2 and PDGF decreased significantly after treatment in experimental group, demonstrating that Endostar could reduce angiogenesis, increase tumor cell apoptosis and inhibit tumor growth in gastric cancer. An investigation of small-sample Endostar concomitant with chemotherapy on patients with advanced gastric cancer primarily indicated the efficacy and feasibility of Endostar concomitant with chemotherapy in treating gastric cancer.
With the expanded application of Endostar in clinic, it also obtains certain effect in treating patients with lung cancer and colorectal cancer. The safety, efficacy, evaluation of relationship between benefit and risk in common or special population as well as the modified dosage of administration of Endostar in wide application should be further explored to provide sufficient scientifical basis for the safety, efficacy, applicable rule in special population and investigation of optimal administrative protocols for Endostar in wide application.
This control, single-center clinical study of EndostarTM Injection with/without SOX protocols to treat advanced gastric cancer was conducted to explore the feasibility, efficacy and safety of Endostar concomitant with SOX protocols, and to provide more evidence-based medical basis for the clinical application of Endostar.
研究类型
注册 (预期的)
阶段
- 第三阶段
联系人和位置
学习地点
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Xinjiang
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Urumqi、Xinjiang、中国、830011
- Cancer Hospital of Xinjiang Medical University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age: 18～70 years;
- Performance status (PS) of Eastern Cooperative Oncology Group (ECOG) was 0～1 or KPS scores were 60-100 scores;
- Patients who were diagnosed with recurrent and metastatic advanced gastric cancer by histopathology and CT;
- Patients who had more than 1 measurable nidus (common CT or MRI scanning ≥20 mm, spiral CT scanning ≥10 mm);
- Patients who had no severe dysfunction of important organs, and were normal in blood routine test, hepatorenal function, electrolytes and cardiac function, with white blood cell count≥4.0×109/L, neutrophil count≥1.5×109/L, platelet count≥100×109/L, hemoglobin≥95g/L, serum bilirubin≤1.5 folds of upper normal limit, Alanine transaminase and glutamic oxalacetic transaminase ≤2 folds of upper normal limit, and serum creatinine≤1.5mg/dl.
- Estimated survival time was above 3 months;
- Patients who were well acknowledged of this study and signed the informed consent forms.
Exclusion Criteria:
- Patients who received whole body treatment of metastatic gastric cancer previously;
- Patients who underwent surgeries within 4 weeks before this study;
- Patients who had allergic constitutions or were allergic to biological products of proteins and to any medicine used in this study;
- Female patients in gestation or lactation period, or those who were interfile but received no contraception measures;
- Patients who were with other symptoms unsuitable to this study;
- Patients who were treated by other anti-tumor methods at that time;
- Patients who had no measurable nidus;
- Patients who had one of the following conditions: uncontrolled metastatic nidus in central nervous system, dysfunction of important organs, severe cardiac diseases (including congestive heart failure, uncontrollable arrhythmia, angina pectoris needed long-term drug treatment, valvular heart diseases and myocardial infarction), hypertension, women in gestation or lactation period, protracted infectious wound as well as uncontrollable psychosis history.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Oxaliplatin & Endostar injection
Oxaliplatin, 130 mg/m2 , iv, 3-4h, d1; Gimeracil and Oteracil Potassium Capsules, 40 mg/m2, po., Bid., d1-14; Endostar injection, 7.5 mg/m2/d, 2 mL/h continuous pumping into vein, d1-10; 21 d as a cycle.
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130mg/m2 , iv, 3-4h, d1, 21 d as a cycle.
其他名称：
40 mg/m2, po., Bid., d1-14, 21 d as a cycle.
其他名称：
7.5 mg/m2/d, 2 mL/h continuous pumping into vein, d1-10, 21 d as a cycle.
其他名称：
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有源比较器：Oxaliplatin
Oxaliplatin, 130 mg/m2 , iv, 3-4h, d1; Gimeracil and Oteracil Potassium Capsules, 40 mg/m2, po., Bid., d1-14, 21 d as a cycle.
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130mg/m2 , iv, 3-4h, d1, 21 d as a cycle.
其他名称：
40 mg/m2, po., Bid., d1-14, 21 d as a cycle.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Response rate (RR)
大体时间：The patients were followed up for 3 years.
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The patients were followed up for 3 years.
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clinical benefit rate (CBR)
大体时间：The patients were followed up for 3 years.
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The patients were followed up for 3 years.
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progression-free survival (PFS)
大体时间：The patients were followed up for 3 years
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PFS was from randomization to tumor progression or death.
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The patients were followed up for 3 years
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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overall survival (OS)
大体时间：The patients were followed up for 3 years
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The patients were followed up for 3 years
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合作者和调查者
赞助
调查人员
- 研究主任：Tang Yong, Professor、Cnacer Hospital of Xinjiang Medical University
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Oxaliplatin的临床试验
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Hospices Civils de Lyon未知