Phase II study of DCS-T
Phase 2
Recruiting
- Conditions
- gastric cancer
- Registration Number
- JPRN-jRCTs061180096
- Lead Sponsor
- Takayama Tetsuji
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
1)Written informed consent.
2)Histologicaly (cytologically) proven gastric cancer.
3)HER2 positive by IHC or FISH method
4)Unresectable gastric cancer.
5)To have measurable lesions.
6)No prior chemotherapy or no influence of prior therapy.
7)Tolerable function of bone marrow, liver and kidney.
8)LVEF more than 50%
9)PS 0 - 1.
10)Expected survival for 3 months.
11)Possible oral intake.
Exclusion Criteria
1)History of hypersensitivity to DCS.
2)Contraindication to TXT, CDDP, S-1, G-CSF.
3)Infectious disease.
4)Severe compliaction.
5)Brain metastasis with clinical symptoms.
6)Watery diarea.
7)Active double cancer.
8)Persons to be pregnant or to make pregnant.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate
- Secondary Outcome Measures
Name Time Method median survival time (OS), progression-free survival(PFS)