KCT0003379进行中（未招募）未知
A phase III study to assess the immunogenicity and safety of PCV-13 during adjuvant chemotherapy
Chonnam National University Hospital Hwasun Hospital0 个研究点目标入组 92 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 92
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 80(Year)（—）
- 性别
- All
入选标准
- •Eligible patients (aged = 19 years) had underwent surgical resection for primary gastric or colorectal cancer and scheduled for adjuvant chemotherapy (fluoropyrimidine ± oxaliplatin), an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less, and adequate hematological, renal, hepatic function within 2 weeks of randomization (absolute neutrophil count =1,500/mm3, platelet count =100,000/mm3, serum creatinine = 1.5 X the upper limit of normal [ULN] or estimated glomerular filtration rate [eGFR] > 50 mL/min calculated by Cockcroft-Gault equation, serum aspartate aminotransferase [AST] and alanine aminotransferase [ALT] = 3 X the ULN, and total bilirubin = 2 X the ULN).
排除标准
- •Exclusion criteria included previous pneumococcal vaccination, hypersensitivity to diphtheria toxin or other compounds of the vaccine, history of immunodeficiency disorders or autoimmune diseases, use of immunomodulatory drugs within 3 months of randomization, and signs of infection within 24 hours of vaccination.
研究者
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