Study of Ramucirumab With TrifluridineTipiracil or Paclitaxel in Adults With Previously Treated Advanced Gastric or Gastroesophageal Junction Cancer

What this Trial Is About

This trial evaluates treatment options for patients with advanced gastric or gastroesophageal junction cancer that has spread and who have previously received treatment. It compares the combination of ramucirumab with trifluridinetipiracil against ramucirumab with paclitaxel, aiming to see if the oral chemotherapy combination is not worse than the standard paclitaxel combination. Ramucirumab targets tumor blood vessel growth, while trifluridinetipiracil and paclitaxel work by damaging cancer cells or blocking their division. Participants are randomly assigned to one of two treatment groups. One group takes oral trifluridinetipiracil twice daily on specific days in a 28-day cycle and receives intravenous ramucirumab on days 1 and 15. The other group receives intravenous paclitaxel on days 1, 8, and 15 plus intravenous ramucirumab on days 1 and 15. Treatment continues in 28-day cycles for up to 36 cycles unless the disease progresses or side effects become unacceptable. After treatment ends, participants are followed up 30-35 days later and then every three months for up to three years. During the study, participants undergo evaluations of tumor progression, survival, quality of life, and safety over the course of up to three years. Researchers use questionnaires to assess quality of life and monitor adverse events. Blood tests and other clinical assessments are done before and during treatment to ensure participants meet health criteria and to monitor effects. Follow-up visits continue after treatment to track long-term outcomes and well-being.

Ramucirumab and Trifluridine/Tipiracil or Paclitaxel for the Treatment of Patients With Previously Treated Advanced Gastric or Gastroesophageal Junction Cancer