JPRN-jRCT1011200013进行中（未招募）1 期
Phase 1 trial of nivolumab and multisite radiotherapy for advanced gastric cancer (HGCSG2001)
Komatsu Yoshito0 个研究点目标入组 12 人开始时间: 2020年12月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Signed and informed consent
- •2. >= 20 yeaes of age at time of study entry
- •3. Expected life expectancy >= 8 weeks
- •4. Histologically proven adenocarcinoma
- •5. advanced or recurrent gastric cancer
- •6. previously
- •7. WIth two or more mesurable disease (RECIST v 1.1)
- •8. ECOG PS 0 or 1
- •9. More than 14 days has passed from prior therapy
- •10. Hematological status: neutrophils(ANC)>=1.2x109/L; platelets >=75x109/L; haemoglobin >=9g/dL, Adequate renal function: Ccr >=40mL/min, Adequate liver function: serum bilirubin <=1.5 x upper normal limit(ULN), AST/ALT< 2.5 x the ULN for the reference lab unless liver metastases are present, in which case it must be =<5x
排除标准
- •1. Active double cancer
- •2. Concurrent enrolment in another clinical study, unless it is an observational clinical study or during the follow-up period of an interventional study
- •3. Any unresolved toxicity CTCAE Grade >= 2 from previous anticancer therapy with the exception of
- •alopecia, vitiligo and neuropathy
- •4. History of allogenic organ transplantation
- •5. severe pleural effusion or acsites
- •6. Interstitial pneumonia and pulmonary fibrosis
- •7. Severe complication
- •8. Infectious disease
- •9. Active viral hepatitis
- •10. Severe diabetes mellitus
- •11. Severe psychological disorders
- •12. Severe cardiovascular disease
- •13. Brain metastasis with clinical symptoms
- •14. systemic steroid use
- •15. Persons to be pregnant or to make pregnant
- •16. Contraindication to nivolumab
- •17. Participation in the clinical trial is determined as unsuitable
研究者
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