CTRI/2023/07/054679尚未招募Unknown
COMPARISON OF EFFICACY & SAFETY OF TWO FRONTLINE CYTOTOXIC CHEMOTHERAPY REGIMENS IN NEWLY DIAGNOSED CANCER OF BILIARY TRACT:A PROSPECTIVE RANDOMIZED CONTROL CONTROL STUDY
O SPONSOR0 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
- Unknown
- 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.Age >=18 years
- •2.ECOG performance status 0,1,2,3
- •3.Histologically confirmed biliary tract cancer.
- •4.Radiologically confirmed unresectable or metastatic disease.
- •5.Patient with Haemoglobin level more than 9%
- •6.Patient with platelet count more than 100,000
- •7.Patient with serum Bilirubin level less than 5gm/dl
- •8.Patients with mild to moderate grade transaminitis, SGOT and SGPT level less than 3X of UNL
- •9.Estimated GFR more than 45 mL/min as measured by the Cockcroft-Gault method14
- •10.Left ventricular ejection fraction >=40%
- •11.Chemotherapy naïve patients
排除标准
- •1. Age less than 18 years
- •2. End-stage kidney disease requiring haemodialysis
- •3. New York Heart Association grade III or IV congestive heart failure, or history of unstable angina/ myocardial infarction within six months prior to study entry
- •4.Grade 2 or worse peripheral neuropathy
- •5.Serum SGOT/SGPT levels >5 times the upper normal limits (UNL) provided, Serum Bilirubin (Total) >3 times the UNL.
- •6.Any acquired immunodeficiency state
- •7.Presence of second malignancy
- •8. Pregnant or Lactating females.
- •9.Surgically resectable tumors
- •10. Active infections
研究者
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