CTRI/2018/06/014652尚未招募2 期
A phase II Clinical Trial Evaluating Efficacy and Safety of Hydroxychloroquin in combination with Gemcitabine and Cisplatin in Muscle Invasive Urothelial Carcinoma of Urinary Bladder
SERB0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
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
- •1. Histologically confirmed muscle invasive transitional cell carcinoma of the bladder
- •2. MIBC Clinical stage T2b through T4a N0/X M0 disease qualifying for neoadjuvant chemotherapy
- •3. Both male and female participants, aged >= 18 years
排除标准
- •1. Hypersensitivity to HCQ
- •2. Chronic and serious hepatic disease with impaired hepatic function
- •3. Chronic and serious renal disease with impaired renal function
- •4. Chronic and serious gastro-intestinal disease
- •5. Chronic Neurological disease (including epilepsy)
- •6. Chronic and serious hematological disease
- •7. Psoriasis
- •8. Porphyria
- •9. G6PD deficiency
- •10. Prior systemic chemotherapy (prior intravesical therapy is allowed)
- •11. Serious intercurrent psychiatric illness.
- •12. Prior radiation therapy to the bladder.
- •13. Concomitant use of any other investigational drugs
- •14. Any of the following within the 6 months prior to study drug administration: myocardial infarction, grade 2 or greater peripheral vascular disease, arterial thrombotic event, visceral arterial ischemia, cerebrovascular ischemia, transient ischemic attack, percutaneous transluminal angioplasty or stent, or unstable angina.
- •15. Symptomatic and/or serious uncontrolled arrhythmia
- •16. Symptomatic congestive heart failure
- •17. History of interstitial lung disease e.g. pneumo nitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
- •18. Major surgery requiring general anesthesia within 21 days or minor surgery within 14 days of study enrollment. Subjects must have recovered from surgery related toxicities.
- •19. Pulmonary embolism, deep vein thrombosis, or other significant venous event <= 8 weeks before enrollment.
- •19. Active infection requiring systemic treatment or any uncontrolled infections <=14 days prior to enrollment.
- •20. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
- •21. Concurrent treatment on another clinical trial. Supportive care trials, surgical clinical trials or non-treatment trials, e.g. QOL, are allowed.
- •22. Ongoing treatment with therapeutic doses of warfarin (low dose warfarin up to 2 mg daily for thromboembolic prophylaxis is allowed).
- •23. Pregnancy or breast-feeding. All female patients would undergo pregnancy test before start of therapy. Alternatively they may be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy Male patients must be surgically sterile or agree to use effective contraception.
- •24. History of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated with the study participation or investigational product(s) administration or may interfere with the interpretation of the results. Concurrent treatment on another clinical trial. Supportive care trials, surgical clinical trials or non-treatment trials, e.g. QOL, are allowed.
- •26. Ongoing treatment with therapeutic doses of warfarin (low dose warfarin up to 2 mg daily for thromboembolic prophylaxis is allowed).
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