Study of Cetuximab with Toripalimab and Irinotecan for Treating RASBRAF Wild-Type Right-Sided Metastatic Colorectal Cancer

What this Trial Is About

Researchers are evaluating the effectiveness and safety of combining cetuximab with a PD-1 inhibitor toripalimab and irinotecan in patients with refractory right-sided metastatic colorectal cancer who have no mutations in RAS or BRAF genes. This study focuses on a group of patients with limited treatment options due to the aggressive nature of right-sided tumors and the lack of established benefits from EGFR inhibitors in this population. The trial aims to provide new insights for this specific cancer subtype. Participants will receive cetuximab 500 mgm, toripalimab 3 mgkg, and irinotecan 150 mgm by intravenous infusion every two weeks. Treatment will continue until there is no clinical benefit, intolerable side effects occur, a new cancer treatment is started, consent is withdrawn, participants are lost to follow-up, death, or other study-specified reasons. This is a single-arm, phase 2 study that monitors participant response to this combination therapy. During the study, researchers will assess tumor response every 8 weeks using standardized criteria for up to 24 months. They will track disease control, duration of response, progression-free survival, overall survival, and any treatment-related side effects for up to 5 years. Participants will undergo regular clinical evaluations, laboratory tests, and imaging to monitor their health and treatment effects. Follow-up will continue until death or study completion, ensuring thorough observation of outcomes and safety.

Cetuximab, Irinotecan, Toripalimab in RAS/BRAF Wild-type Ultraselected Right-sided Colorectal Cancer Study