Savolitinib Plus Cetuximab and FOLFOX Chemotherapy for RAS/BRAF Wild-type Metastatic Colorectal Cancer

Summary

The goal of this clinical trial is to learn if adding savolitinib to cetuximab plus FOLFOX chemotherapy works as a first-line treatment for patients with RAS/BRAF wild-type metastatic colorectal cancer, and to evaluate its safety. The main questions it aims to answer are: Does the addition of savolitinib improve the objective response rate (ORR) compared to cetuximab plus FOLFOX alone? What medical problems (adverse events) do participants experience when taking savolitinib in combination with cetuximab and FOLFOX? Researchers will compare savolitinib plus cetuximab and FOLFOX (experimental group) versus cetuximab and FOLFOX alone (control group) to see if the triplet regimen provides better tumor response and survival outcomes. Participants will: Take oral savolitinib once daily in repeated 14-day cycles (or receive control treatment), combined with weekly cetuximab and bi-weekly FOLFOX chemotherapy Visit the clinic every 2 weeks or 4 weeks for treatment administration, safety monitoring, and laboratory tests Undergo tumor imaging assessments every 8 weeks (4 cycles) to evaluate treatment response and disease progression Have regular follow-up visits for 30 days after the last dose, and then every 3 months for survival follow-up

Timeline

Start

2026-06-30

Primary completion

2028-06-30

Completion

2029-06-30

Drugs

Indications