KCT0003478撤回未知
A Phase II Study of concurrent chemo-radiotherapy with Gemcitabine followed by chemotherapy with Gemcitabine and Cisplatin for unresectable localized perihilar cholangiocarcinoma
CC Hospital0 个研究点目标入组 27 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 撤回
- 发起方
- 入组人数
- 27
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 o Limit（—）
- 性别
- All
入选标准
- •Pathologically confirmed adenocarcinoma located in the bile duct of the liver,
- •If surgically unresectable
- •If there is no systemic and intrahepatic metastasis
- •If there is biliary obstruction, there is no obstruction due to drainage before the clinical trial
- •If the tumor is included in the radiation field (maximum: 10 x 10 cm)
- •If the tumor is measurable,
- •If there is no history of radiation therapy in the abdomen
- •Age: = 18 years old
- •Performance status: ECOG 0-1
- •With adequate bone marrow, renal, and liver function: HB =9.0 g/dl, ANC =1,500/mm3, PLT = 100,000/mm3, Bilirubin <3.0 mg/dl, AST/ALT/ALP): < WNL X 3, Creatinine: <WNL x 1.5
- •If you decide to voluntarily participate in this trial and you have signed a written informed consent
- •Age: < 18 years old
排除标准
- •Biliary cancer of other histological type except adenocarcinoma.
- •Cholangiocarcinoma with a epicenter other than perhilar area
- •In case of peritoneal seeding and distant metastasis
- •Performance status: ECOG 2-4.Previous radiotherapy history to target area
- •The patients with other tumors not treated in addition to biliary cancer within the last 2 years. However, cervical intraepithelial and thyroid cancer and early (I, II) prostate cancer are acceptable.
- •If you have any of the following serious systemic diseases: congestive heart failure (NYHA class III or IV); unstable angina within the last 6 months, myocardial infarction, Arrhythmia requiring treatment beyond 2nd degree AV block, uncontrolled hypertension, Child C liver cirrhosis, interstitial pneumonia, pulmonary adenomatosis, Mental illness that may interfere with treatment and clinical trials, unstable diabetes mellitus, uncontrolled ascites or pleural effusion, active infection
- •If the investigator judges that the patient is inadequate to participate in the clinical trial
研究者
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