JPRN-jRCTs041210105
Recruiting
Phase 2
Phase II study investigating efficacy and safety of trifluridine/tipiracil (FTD/TPI) plus ramucirumab (Ram) as third-line or later treatment for advanced gastric cancer
Kodera Yasuhiro0 sites32 target enrollmentNovember 22, 2021
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- gastric cancer
- Sponsor
- Kodera Yasuhiro
- Enrollment
- 32
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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