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

JRCT ID: jRCTs041210105

Registered date:22/11/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: gastric cancer
• Date of first enrollment: 22/02/2022
• Target sample size: 32
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: Time to treatment failure
• Secondary Outcome: Adverse event rate, overall survival time, disease-free survival time, response rate, disease control rate, relative dose intensity

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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
11) Patients with ineligible for the study at the physician's assessment

Related Information

• Primary Sponsor: Kodera Yasuhiro