A phase II study of S-1/Cisplatin/Trastuzumab for human epidermal growth factor receptor 2 (HER2)-positive advanced and/or recurrent gastric cancer

Phase 2

• Conditions: advanced and/or recurrent gastric cancer

• Registration Number: JPRN-UMIN000006603
• Lead Sponsor: HOG-GC (Hiroshima oncology group of gastric cancer)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-24
• Study Completion: 2015-02-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

1) history of a previous drug allergy 2) pregnant or nursing patient or with intent to bear baby 3)R1 gastrectomy 4)need continuing use of flucytosine, phenytoin, warfarin potassium 5)Active infection or other inflammatory disease 6)with severe allergy to Trastuzumab, S-1 and cisplatin 7)History of cardiac disease 8)patients with serious concomitant diseas 9)with diarrhea 10)with ascites or pleural effusion 11)with multiple bone metastasis 12)peripheral sensory neuropathy 13)with brain metastasis 14)received operation within 28 days 15)simultaneous or metachronous double cancers 16)with clinically important mental disorder need to treat 17)cannot stopped steroids or immunosuppressing drug 18)Infection with hepatitis B 19)Inappropriate for the trial at the physician's assessment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response rate

Secondary Outcome Measures

Name	Time	Method
Progression free survival, Overall survival, Safety,