Study of Irinotecan Liposome with Fluorouracil and Bevacizumab or Cetuximab as Second-Line Treatment for Advanced Colorectal Cancer

What this Trial Is About

Researchers are evaluating the use of liposomal irinotecan II combined with fluorouracil and either bevacizumab or cetuximab for the second-line treatment of patients with advanced metastatic colorectal cancer. This phase 2 study focuses on comparing the efficacy and safety of these combinations, as guidelines recommend FOLFIRI with bevacizumab or cetuximab for this condition. Liposomal irinotecan may offer improved treatment results compared to ordinary irinotecan. Participants receive either irinotecan liposome II and fluorouracil with bevacizumab or irinotecan liposome II and fluorouracil with cetuximab. The treatment includes an induction phase and a maintenance phase, where bevacizumab or cetuximab is combined with irinotecan liposome II or Capecitabine. These regimens are studied to monitor their impact on cancer progression and patient safety. During the study, participants undergo regular assessments including imaging scans to measure tumor response, evaluations of progression-free and overall survival, and monitoring for adverse events. Quality of life is also assessed. The study lasts for about one year on average for the primary outcome and up to 50 months for safety and quality of life evaluations. The trial aims to gather detailed information on how patients respond and tolerate these treatments over time.

Clinical Study of Second-line Treatment in Advanced Colorectal Cancer With Chemotherapy With Bevacizumab or Cetuximab