Advanced or metastatic gastric cancer
Conditions
Interventions
Propagermenium (30mg/day, every day)
Sponsors
Hyogo College of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed gastric cancer 2) resistant /intolerable to other treatments 3) Measurable or non-measurable disease 4) Adequate oral intake 5) Age >= 20 years 6) Eastern Cooperative Oncology Group Performance status is 0,1,2. 7) Negative HBe antigen and no liver cirrhosis 8) Adequate renal function 9) No prior immunotherapy 10) Treatment in out-patient clinic is feasible. 11) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Active concomitant malignancy 2) Active infection 3) High fever (>38 degree) at registration 4) Pregnant, nursing or unwilling to practice contraception during the study 5) Poorly controlled diabetes mellitus 6) medication of steroid 7) Severe diabetes mellitus 8) Unstable angina or acute myocardial infarction within 6 months 9) Severe organ failure ( renal, hepatic pulmonary disease) 10) Active bleeding 11) Massive pleural effusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events, feasibility, disease control rate, progression free survival, proportion of treatment related death, and performance status. | — |
Countries
Japan
Contacts
Public ContactShojiro Kikuchi
Hyogo College of Medicine Surgery
Outcome results
None listed