JPRN-jRCTs051180122招募中2 期
Randomized phase II study of gemcitabine and S-1 combination therapy versus gemcitabine and nanoparticle albumin-bound paclitaxel combination therapy in locally advanced pancreatic ductal adenocarcinoma - PDAC-GS/GA-rP2
Kobayashi Syogo0 个研究点目标入组 100 人开始时间: 2019年3月13日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
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. Histologically or cytologically confirmed adenocarcinoma, adenocarcinoma squamous carcinoma of pancreatic cancer.
- •2. Patients of age =>20
- •3. Performance Status:0-1(ECOG)
- •4. Resectable pancreatic cancer
- •5. Life expectancy more than 6 months.
- •6. Sufficient organ functions.
- •(1) neutrophils >=1,500/mm3
- •(2) platelets >=100,000/mm3
- •(3) hemoglobin >=9.0g/dl
- •(4) AST(GOT)/ALT(GPT) <=150IU
- •(5) total bilirubin <=2.0mg/dl
- •(or <=3.0mg/dl if biliary drainage were present)
- •(6) serum creatinine <=1.2mg/dl
- •(7) creatinine clearance>=60ml/min
- •7. No treatment before application for this tumor
- •8. Written informed consent.
排除标准
- •1) Unresectable pancreatic cancer
- •2) Lung fibrosis or intestinal pneumonia, and anamnesis or imaging findings.
- •3) Patients with Brinkman Index =>200
- •4)Watery diarrhea 5) Severe infection
- •6) Severe complication
- •(heart failure, renal failure, hepatic insufficiency,hemorrhagic peptic ulcer, intestines paralysis,ileus or uncontrolled diabetes etc)
- •7) Massive pleural or abdominal effusion.
- •8) Metastasis to central nervous system.
- •9) Active synchronous or metachronous malignancy other than carcinoma in situ.
- •10) Regular use of frucitocin, fenitoin or warfarin
- •11) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy
- •12) Severe mental illness 13) Severe allergy for drugs
- •14) Patients who are judged inappropriate
- •for the entry into the study by the investigator.
研究者
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