NCT02466906Unknown2 期
Recombinant Human Granulocyte-macrophage Colony-stimulating Factor as Adjuvant Immunotherapy in Treating Resectable Stage III Colon Cancer: A Randomized, Placebo-controlled Clinical Trial
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Disease-free survival（DFS）
研究概览
简要总结
This study is to investigate the efficacy and safety of rhGM-CSF as adjuvant immunotherapy for patients with resectable stage III colon cancers.
详细描述
This study is to investigate the efficacy and safety of rhGM-CSF as adjuvant immunotherapy for patients with resectable stage III colon cancers. Patients were randomly assigned to rhGM-CSF group or placebo group and treated with rhGM-CSF or placebo perioperation and during the adjuvant chemotherapy. The purpose of the study is to evaluate the antitumor immune effect of rhGM-CSF before surgery and adjuvant chemotherapy through DFS of 5 years and to observe the safety during the treatment in order to provide evidence for improvement in treating resectable colon cancer patients.
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
- Single (Participant)
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
- •Diagnosed as resectable stage III colon cancer
- •18-70 years old
- •ECOG performance status ≤2
- •Unexposed to rhGM-CSF in 6 months
- •Signed an informed consent document
排除标准
- •Secondary primary cancer, or concurrent primary malignancies (except for basal cell or squamous cell skin cancer, cervical cancer in situ, and other cancer with disease free for more than 5 years)
- •Complete intestinal obstruction
- •Events within 6 months before randomization: myocardial infarction, sever or unstable angina, coronary artery or peripheral arterial bypass surgery, congestive heart failure ( NYHA functional class of III or IV ), stroke and any myocardial dysfunction in a transient ischaemic attack
- •Abnormal liver and kidney function (Serum creatinine > 1.5 x ULN, total bilirubin > 1.5 x ULN, transaminase > 3 x ULN ), abnormal pulmonary function (FEV1<60% or diffusing capacity of the lung for carbon monoxide < 55% )
- •Bone marrow dysfunction ( Hb<9.0 g/dL、ANC<1.5 x 109/L、PLT<100 x 109/L )
- •ITP or immunodeficiency
- •Uncontrolled infection, including HBV, HCV, HIV infection
- •Female patients who has been pregnant or planning to, and those during lactation
- •Known allergic to E.coli agents or rhGM-CSF or any severe allergic history to other drugs
- •Other cases that the researcher found ineligible
研究组 & 干预措施
rhGM-CSF group
Experimental
rhGM-CSF was injected subcutaneously perioperation.
干预措施: rhGM-CSF (Drug)
placebo group
Placebo Comparator
Placebo was injected subcutaneously perioperation.
干预措施: placebo (Drug)
结局指标
主要结局
Disease-free survival（DFS）
时间窗: 5 years
次要结局
- Overall survival (OS)(5 years)
- Incidence of liver metastasis(5 years)
- Immune anti-tumor effect: DC cells, CD4+ cells, CD8+ cells, Treg cells(5)
- Adverse effects (AE)(5 years)
研究者
研究点 (1)
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