Trifluridine/tipiracil (FTD/TPI) plus ramucirumab (Ram) for advanced gastric cancer
- Conditions
- gastric cancerGastric cancer
- Registration Number
- JPRN-jRCTs041210105
- Lead Sponsor
- Kodera Yasuhiro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 32
1) Histologically confirmed gastric cancer; one of the general types of histological classification or gastric carcinoma with lymphoid stroma
2) Histologically confirmed unresectable, advanced or recurrent gastric cancer (including esophago-gastric junctional cancer)
3) Must be refractory or ineligible to at least 2 prior lines of standard of care systemic therapy.
4) 20 years and over of age on the day of signing informed consent
5) Patients with adequate oral intake
6) Performance status (PS) 0-2
7) Adequate function of vital organs, including bone marrow, liver, and kidney within 14 days before registration
8) Written informed consent
1) Patients previously received FTD/TPI
2) Patients with active double cancer
3) Patients with active infectious disease
4) Females who are pregnant or breastfeeding or plans of pregnancy, males who wish that his partner to be pregnant
5) Patients with grade 3 or higher peripheral neuropathy
6) Patients with grade 2 or higher diarrhea
7) Patients with serious non-healing wound, ulcer, or bone fracture
8) Patients with serious complications
9) Patients with psychiatric disease
10) Patients with a history of allergy to ramucirumab or severe hypersensitivity to the components contained in the study drug
11) Patients with ineligible for the study at the physician's assessment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method