Phase I/II multicenter clinical trial of S-1/CDDP/Trastuzumab combination chemotherapy for HER2-positive Stage IV advanced gastric cancer
Phase 1
Recruiting
- Conditions
- HER2-positive Stage IV advanced gastric cancer
- Registration Number
- JPRN-UMIN000007436
- Lead Sponsor
- Dept. of Gastrointestinal Surgery, The University of Tokyo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 55
Inclusion Criteria
Not provided
Exclusion Criteria
1. Malignant tumor of other organs 2. Severe medical condition 3. Active bleeding from gastrointestinal tract 4. Poor oral intake 5. Contraindication for S-1, CDDP or Trastuzumab
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate
- Secondary Outcome Measures
Name Time Method Safety - Type and grade of adverse event - Frequency of adverse events Efficacy - Time to treatment failure(TTF) - Progression free survival(PFS), - Overall survival(OS)