Phase II study of TAS-114 in combination with S-1 in patients with advanced gastric cancer refractory to prior chemotherpy.
- Conditions
- gastric cancer
- Registration Number
- JPRN-UMIN000028329
- Lead Sponsor
- ational Cancer Center Hospital East
- Brief Summary
ORR 5%, DCR 70%
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
1)Administration of chemotherapy within 2 weeks prior to enrollment 2)Major surgery or radiation therapy within 4 weeks prior to enrollment. Except bowel bypass surgery or enterostomy has passed over 2 weeks. 3)Investigational drugs was administrated within 4 weeks prior to enrollment 4)Prior chemotherapy with TAS-114. 5)Known hypersensitivity to S-1 or excipients. 6)Patients with CNS metastases. 7)Synchronous or asynchronous (within 3 years) other cancer except carcinoma in situ or intramucosal carcinoma. 8)Any severe and/or uncontrolled medical conditions. 9)Active hepatitis 10)Chronic treatment with steroids or another immunosuppressive agent. 11)Patient is unwilling to practice appropriate contraception during the study and the contraception period after the discontinuation of the protocol treatment 12)Patient is unwilling or unable to comply with the protocol 13)Patient is judged by the investigator to be inappropriate for study participation for any reason.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method