KCT0003726终止未知
A phase III clinical study to compare paclitaxel (Genexol®-PM) in combination with standard therapy (gemcitabine/cisplatin) and standard therapy alone (gemcitabine/cisplatin) in patients with advanced biliary tract cancer
适应症
试验速览
- 阶段
- 未知
- 状态
- 终止
- 入组人数
- 220
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
- 19(Year) 至 79(Year)（—）
- 性别
- All
入选标准
- •Patients between 19 and 79 years old
- •- Cytologically or histologically confirmed adenocarcinoma of biliary tract (gallbladder, intrahepatic, and extrahepatic bile ducts) with or without measurable lesion according to RECIST version 1.1
- •- Locally advanced unresectable, initially metastatic, and recurred disease
- •- At least one or more evaluable lesions without prior radiotherapy
- •- Patients with or without prior external or internal biliary drainage procedure (e.g., percutaneous transhepatic biliary drainage, endoscopic retrograde biliary drainage)
- •- No previous chemotherapy except adjuvant chemotherapy with fluoropyrimidine-based regimen which completed 6 months or before
- •- Eastern Cooperative Oncology Group (ECOG) performance status 0 ~ 2
- •- Adequate bone marrow function as defined by platelets = 100 x 109/L and neutrophils = 1.5 x 109/L
- •- Adequate renal function, with serum creatinine < 1.5 x upper limit of normal (ULN)
- •- Adequate hepatic function with serum total bilirubin < 1.5 mg/dL, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 5 x ULN
- •- No other malignant disease apart from non-melanotic skin cancer or carcinoma in situ of the uterine cervix or any other non life-threatening cancer (i.e., prostate or thyroid cancer) except where treated with curative intent > 5 years previously without evidence of relapse
- •- Written informed consent to the study
排除标准
- •- Age=80 years
- •- Histologically diagnosed adenosquamous carcinoma
- •- AoV cancer
- •- History of severe neurologic disorder or psychiatric disorder
- •- Radiation therapy taken within 4 weeks
- •- Gastrointestinal obstruction
- •- Severe gastrointestinal bleeding
- •- Medical history with coronary angioplasty, stent insertion, bypass within 6months
- •- Myocardial infarction or other clinically significant heart disease within 6 months of initiation of the study treatment
- •- High risk of cardiovascular conditions (including patients with recent coronary stent implantations, with myocardial infarction within 6 months, and with arrhythmia with unstable symptoms)
- •- Past or present history of uncontrolled HIV, uncontrolled hepatitis B or C (in case of chronic hepatitis B or HBV carrier, HBV DNA level should be lower than 200IU/mL)
- •- Severe and/or uncontrolled medical conditions which may interfere with participation in the study, including significant active or uncontrolled infection (bacterial, viral, and fungal infection)
- •- Allergy or hypersensitivity reaction to paclitaxel, gemcitabine, cisplatin, or Cremophor EL; patients with symptoms in Contraindications and Precautions
- •- Patients with genetic problems including galactose intolerance, lapp lactose deficiency or glucose-galactose malabsorption
- •- interstitial pneumonitis or pulmonary fibrosis clearly visible on the x-ray with clinical symptoms
- •- Hearing impairment
- •- Cisplatin-induced neuropathy
- •- Other serious diseases or medical conditions
- •- Pregnant or lactating women or women of childbearing potential who do not consider appropriate contraceptives
研究者
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