CTRI/2019/02/017562进行中（未招募）2 期
A pilot study to assess safety and efficacy of modified FOLFIRINOX in unresectable Gall Bladder Cancer
ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI0 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
- 进行中（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
- •a.Histologically proven cases of adenocarcinoma of gall bladder
- •b.Subjects having measurable disease which is considered unresectable or metastatic
- •c.Written consent is obtained
- •d.ECOG Performance status < 1.
- •e.Age >18 years
- •f.Adequate bone marrow functions reflected as Hb ï?¾ 10gm/dl, TLC ï?¾4,000/cmm ( ANCï?¾1,500/cmm), and Platelets ï?¾1,00,000/cmm)
- •g.Serum creatinine ï?¼ 1.8 mg%
- •h.Serum bilirubin ï?¼3 mg%
- •i.Liver enzymes (SGOT and SGPT) within 3 times the upper normal limit, upto 5 times in case of diffuse liver involvement
- •j.Prior adjuvant chemotherapy/radiotherapy allowed, provided there is more than 6 months of gap between last chemotherapy/radiotherapy and recurrence
- •k.Prior radical surgery is allowed if recurrence is unresectable
排除标准
- •a.Women of reproductive age group not practicing contraception
- •b.Lactating and pregnant women
- •c.Patients who are on other investigational drugs
- •d.Patient unwilling to give written informed consent
- •e.Known history of HIV, hepatitis B or hepatitis C infection
- •f.Symptomatic neuropathy
- •g.Uncontrolled concurrent diabetes, hypertension or cardiac disorder
研究者
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