Phase 2 Study Comparing Fruquintinib with or without TAS-102 for Treating Advanced or Metastatic Colorectal Cancer that Does Not Respond to Prior Treatments

What this Trial Is About

This trial is studying patients with advanced or metastatic colorectal cancer that is microsatellite stable and has not responded to previous treatments. Researchers are comparing a combination of the drugs fruquintinib and TAS-102 to fruquintinib alone to see which treatment may better control the cancer. This is a randomized Phase 2 study sponsored by Criterium, Inc., focusing on patients who have already received several standard therapies for colorectal cancer. Participants will be randomly assigned to receive either fruquintinib combined with TAS-102 or fruquintinib alone. Both treatments involve oral medications taken by the patients. The study is designed to last up to 24 months, during which the effects of the treatments on cancer progression and patient survival will be closely monitored. Researchers will also track side effects to understand the safety profile of the combination therapy compared to fruquintinib alone. Throughout the trial, participants will undergo regular assessments including scans to measure tumor size, blood tests to check organ function and blood counts, and evaluations of their overall health and ability to perform daily activities. The main outcome is progression-free survival, meaning how long the cancer stays under control without worsening. Other outcomes include response rate, disease control, clinical benefit, overall survival, and treatment-related side effects. Participants will be followed closely for up to two years to gather this information.

A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients With Refractory Advanced/Metastatic Colorectal Cancer