臨床研究等提出・公開システム

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

Trifluridine/tipiracil (FTD/TPI) plus ramucirumab (Ram) for advanced gastric cancer

Kanda Mitsuro

Nagoya University Graduate School of Medicine

65 Tsurumai-cho, Showa-ku, Nagoya , Aichi

m-kanda@med.nagoya-u.ac.jp

Nakanishi Koki

Nagoya University Hospital

65 Tsurumai-cho, Showa-ku, Nagoya , Aichi

+81-52-744-2250

konakani@med.nagoya-u.ac.jp

Not Recruiting

Nov. 22, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

Both

gastric cancer

Patients receive trifluridine/tipiracil (35 mg/m2) orally twice daily on days 1-5 and days 8-12 of each 28 day treatment cycle, plus intravenous ramucirumab (8 mg/kg) on days 1 and 15, followed until disease progression or unmanageable toxicity.

Gastric cancer

Chemotherapy

Time to treatment failure

Adverse event rate, overall survival time, disease-free survival time, response rate, disease control rate, relative dose intensity

+81-52-744-2479

Nov. 08, 2021

none