large type 3 or type 4 gastric cancer
Conditions
Interventions
Intervention type:DRUG
Name of intervention:SPP-006(20 or 40 mg/kg)
Dose form / Japanese Medical Device Nomenclature:GRANULES
Route of administration / Site of application:ORAL
Dose per administration
Sponsors
Osaka University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Japanese patients who meet all of the following criteria are included in this clinical trial. 1)Age older than 20 years 2)Macroscopic finding is type 4 or type 3 whose size is over 8 cm by endoscopy and/or CT 3) ECOG Performance Status 0-1 4)Patients without 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.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria are excluded from this trial 1) Patient with poor controlled infection 2)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. 3) Patients with current bone marrow transplantation 4) Patient with severe mental disorder 5) Patient with known allergy to 5-ALA or a similar compound 6) Participation in other clinical studies with investigational drugs concurrently 7) Pregnant or breast-feeding 8) Patient is judged exclusive by investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Adverse event rate with each CTCAE grade | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity,specificity,positive predictive value, negative predictive value,the ratio of patients with peritoneal metastases | — |
Countries
Japan
Contacts
Public ContactTsuyoshi Takahashi
Osaka University Hospital
Outcome results
None listed