Exploratory study of Paclitaxel+Trastuzumab therapy for advanced or recurrent gastric cancer with HER2 positive.
- Conditions
- advanced or recurrent HER2-positive gastric cancer
- Registration Number
- JPRN-UMIN000008623
- Lead Sponsor
- The Cancer Institute Hospital of JFCR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 36
Not provided
1) Patient with a previous history of serious drug hypersensitivity. . 2) Patient with infectious diseases associated with a fever of 38.0 degrees C or higher 3) Patient with serious complications (interstitial pneumonia or pulmonary fibrosis, difficult-to-control diabetes, renal failure, hepatic failure, and so on) 4) Patient who has heart disease(CHF, old MI, IHD, arrhythmia, and a valvular disease of the heart) 5) Poorly-controlled hypertension 6) Patient with synchronous double cancer or metachronous double cancer with a disease-free interval of less than five years(In-situ cancer, gastric cancer, mucosal cancer, differentiated adenocarcinoma, and skin cancer judged to be cured by treatment are not considered to be active double cancers.) 7) Women of child-bearing potential (intention), pregnant or lactating women 8) Men desiring to have children 9) Patient judged by the investigator(s) to be inappropriate study participants for any other reason
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety ORR:overall response rate Progression free survival rate
- Secondary Outcome Measures
Name Time Method Safety PFS: progression free survival OS: overall survival TTP: Time to treatment failure Prediction of effects based on the number of CTCs and PAC+T therapy Prediction of effects based on markers on CTCs and PAC+T therapy