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临床试验/JPRN-jRCT2091220309
JPRN-jRCT2091220309已完成3 期

The efficacy and safety of photodynamic diagnosis with SPP-005 at staging laparoscopy for advanced gastric cancer. Prospective multi-center trial. - GCPDD Study

Osaka University Hospital0 个研究点目标入组 105 人开始时间: 2017年9月15日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
105

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

年龄范围
>= 20age old 至 ot applicable(—)
性别
All

入选标准

  • 1)Age older than 20 years
  • 2)large type 3 whose size is over 8 cm or type 4 gastric cancer
  • 3)ECOG Performance Status 0~1
  • 4)Patients with any abnormal function in kidney, liver, blood, heart or lung.
  • 5)Patients in treatment without other tumors.
  • 6)Patient in well compliance with protocol and with written informed consent.
  • 7)Patients who are able to visit the hospital according to the protocol schedule.

排除标准

  • 1)Patient who is apparently diagnosed peritoneal dissemination by CT scan.
  • 2)Patient having difficulty in oral ingestion
  • 3)Patient with poor controlled infection
  • 4)Patient with severe complications e.g. malignant hypertension, severe cardiac failure congestive, severe or unstable angina, myocardial infarction within last three months, cirrhosis in terminal stage, severe renal failure, diabetes mellitus poor control, severe pulmonary fibroses, active interstitial pneumonia, and so on.
  • 5)Patients with current bone marrow transplantation
  • 6)Patient with severe mental disorder
  • 7)Patient with known allergy to 5-ALA or a similar compound
  • 8)Participation in other clinical studies with investigational drugs concurrently
  • 9)Patients during pregnancy/lactation period
  • 10)Patient is not judged exclusive by investigator

研究者

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