Randomized Phase II Trial of Trifluridine/tipiracil (FTD/TPI) plus Ramucirumab (RAM) versus Trifluridine/tipiracil in Previously Treated Patients with Advanced Gastric or Esophagogastric Junction Adenocarcinoma. (WJOG15822G)

Hiroki Hara0 sites110 target enrollmentJanuary 21, 2023

Overview

No summary available.

Registry

who.int

Start Date

January 21, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Hiroki Hara

•1\. Age is 20 years or older.
•2\. Histologically diagnosed as adenocarcinoma (general type) of the gastric or esophagogastric junction.
•3\. HER2 test has been performed before registration (regardless of HER status).
•4\. Unresectable progression or recurrence comfirmed by CT scan.
•5\. ECOG performance status (PS) is 0 or 1\.
•6\. Expected to survive for 3 months or more.
•7\. One or more measurable lesions.
•8\. Pretreatment (refractory or intolerant to the following drugs).
•Fluoropyrimidine, Taxane or Irinotecan (Eligible even if you have used both drugs), Ramucirumab (eligible only for refractory cases)
•9\. Organ and bone marrow functions are maintained.

•1\. Have active double cancer (simultaneous double cancer / multiple cancer and metachronous double cancer or multiple cancer with a disease\-free period of 2 years or less).
•2\. Oral intake is difficult. Specifically, cases that require daily infusion for nutrition and water intake purposes even after registration.
•3\. Pre\-treatment including FTD / TPI in the past.
•4\. Have hypersensitivity of the drugs used in this study.
•5\. Past history of major surgery (general anesthesia required) within 4 weeks before registration and radiation therapy covering the abdomen within 2 weeks. However, examination laparoscopy performed for diagnostic purposes is excluded.
•6\. Cases with severe pleural effusion (when occupying more than half of the thoracic cavity, or when frequent thoracentesis is required).
•7\. Have severe ascites or have a history of palliative ascites puncture (excluding test puncture for examination) within 2 weeks.
•8\. Cases with brain metastasis and tumor metastasis to the central nervous system
•9\. Adverse events (non\-hematological toxicity) of poorly controlled Grade 2 or higher (CTCAE v5\.0\) remain at the time of registration (hair loss, dysgeusia, pigmentation, peripheral neuropathy could be registerd even if Grade 2 or higher)
•10\. Have a local or systemic active infection that requires treatment.