CTRI/2023/05/052625尚未招募2 期
A Randomized Controlled, Open Labeled, Two Arm, Study of Addition of Everolimus to Standard of Care in Carcinoma Gallbladder - GBC01
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- BH
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
入选标准
- •Histological proof of cancer with stage III inoperable or Stage IV metastatic disease without any prior treatment.
- •Patients with histologic proof of metastatic gallbladder carcinoma who have not had previous treatment for metastatic disease or who received gemcitabine/capecitabine with or without platinum more than months ago as part of adjuvant therapy
排除标准
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness orsocial situations that would limit compliance with study requirements
- •Clinically significant cardiac disease, especially history of myocardial infarction more than 6 months, or congestive heart failure (New York Heart Association [NYHA] classification III or IV) requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
- •Patients taking strong inhibitors or inducers of CYP3A4
- •Prior therapy with everolimus
研究者
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