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临床试验/CTRI/2015/09/006175
CTRI/2015/09/006175招募中未知

Gemcitabine and oxaliplatin vs gemcitabine and capecitabine in patients with unresectable Carcinoma gall bladder with obstructive jaundice post PTBD/stenting (PTBD or ERCP). A randomized controlled study.

AIIMS0 个研究点目标入组 104 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
招募中
发起方
AIIMS
入组人数
104

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. Patients with biopsy or cytology proven unresectable or metastatic carcinoma gall bladder with obstructive jaundice.
  • 2. Limited liver or peritoneal metastases with good performance status (ECOG < 3)
  • Adequate organ and bone marrow function.
  • 3. Haemoglobin more than 10 g/dl, absolute neutrophil count more than 1.5Ã?109/L, platelets higher than 100 Ã? 109/L.
  • 4. Serum creatinine <1.8 mg/100 mL.
  • 5. Serum bilirubin <3 mg/100 mL, liver enzymes (AST and ALT) within 3 times the normal limit (5 times in case of diffuse hepatic involvement).
  • 6. Eastern Cooperative Oncology Group performance status of <3.
  • 7. Prior adjuvant chemotherapy and/or radiotherapy, if given, should have been completed 6 months before enrollment

排除标准

  • 1 Diffuse metastases in the liver or disseminated disease
  • 2.Gross ascites

研究者

发起方
AIIMS

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