JPRN-UMIN000051689尚未招募Unknown
Phase III study of gemcitabine, cisplatin plus S-1 combination therapy versus gemcitabine, cisplatin plus immune checkpoint inhibitor combination therapy in advanced biliary tract cancer. - YOTSUBA trial
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 460
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
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) Patients who have undergone curative resection with positive pathology margin. 2) Have active overlapping cancers (overlapping cancers that do not define the prognosis and do not require aggressive treatment, such as early-stage cancer, are acceptable). 3) Infectious diseases (excluding viral hepatitis) requiring systemic treatment. Especially, patients with biliary stasis should be enrolled after appropriate drainage and proper control of cholangitis. 4) Patients with a fever of 38 degrees Celsius. or higher at the time of enrollment. 5) Women who are pregnant, possibly pregnant, or lactating. Males who wish to have a partner who is pregnant. 6) Patients with psychiatric disorders or psychiatric symptoms that interfere with their daily life or make it difficult for them to give their consent, difficulty in participating in the research. 7) Receiving continuous systemic administration of steroids (prednisone equivalent > 10 mg/day) or other immunosuppressive drugs for the treatment of autoimmune or other diseases. 8) Complicated by serious complications (heart failure, renal failure, liver failure, intestinal paralysis, intestinal obstruction). 9) Complicated with poorly controlled diabetes mellitus (if controlled prior to enrollment, the patient may be enrolled). 10) Complicated with unstable angina pectoris or a history of myocardial infarction within 6 months prior to enrollment. 11) Complicated interstitial pneumonia, pulmonary fibrosis, or severe emphysema, as diagnosed by CT scan of the chest. 12) Requires continued use of flucytosine, phenytoin, or warfarin potassium. 13) Patient has metastatic disease to the central nervous system (pretreatment head CT/MRI scan not required). 14) Patients with a history of hypersensitivity to any component of the study drug or any other condition that is contraindicated. 15) Patients with water diarrhea 16) Other conditions that the physician deems inappropriate for the safe conduct of this study.
研究者
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