JPRN-jRCTs011190008进行中（未招募）2 期
Phase2 trial of oxaliplatin, irinotecan and S-1 (OX-IRIS) as first line chemotherapy for unresectable pancreatic cancer - HGCSG1803
Komatsu Yoshito0 个研究点目标入组 40 人开始时间: 2019年12月24日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
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 <= 75age old（—）
- 性别
- All
入选标准
- •1. Histologically proven adenocarcinoma or adenosquamous carcinoma of the advanced or recurrent pancreatic cancer
- •2. With measurable disease (RECIST v1.1)
- •3. aged 20 to 75 years old
- •4. ECOG PS 0 or 1
- •5. No prior chemotherapy or radiation therapy (in case of previous neoaduvant therapy, interval from operation and relapse must be >6 months, and in case of previous adjuvant therapy, interval from end of chemotherapy and relapse must be >6 months for S-1 therapy)
- •6. Expected life span >= 8 weeks
- •7. Ingestible
- •8. Hematological status: neutrophils(ANC)>=1.5x109/L; platelets >=100x109/L; haemoglobin >=9g/dL, Adequate renal function: serum creatinine level >=1.2mg/dl, Ccr >=60mL/min, Adequate liver function: serum bilirubin <=2.0 x upper normal limit(ULN), AST/ALT< 2.5 x the ULN for the reference lab
- •9.Signed and dated informed consent
排除标准
- •1. Active double cancer
- •2. UGT1A1 double hetero(UGT1A1*6/*28) or homo(UGT1A1*6 or UGT1A1*28)
- •3. Neuropathy with symptoms
- •4. blood transfusions within 7 days from registration
- •5. severe pleural effusion or ascites
- •6. Watery diarrhea
- •7. Severe complication
- •8. Infectious disease
- •9. Active viral hepatitis
- •10. Brain metastasis with clinical symptoms
- •11. systemic steroid use
- •12. Persons to be pregnant or to make pregnant
- •13. Contraindication to oxaliplatin, Irinotecan, and S-1
- •14. Participation in the clinical trial is determined as unsuitable.
研究者
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