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Cetuximab in Combination With Anti-PD-1 and mFOLFOX Treat For RAS/BRAF wt Right-Sided Colon Cancer — CIFOXRC  

Colonic Neoplasms Clinical Trial

Official title:
A Multiple-Center,Single-arm Clinical Study of Cetuximab in Combination With Anti-PD-1 and mFOLFOX Treat For RAS/BRAF wt Locally Advanced or Metastatic Right-Sided Colon Cancer

Clinical Trial Summary

We plan to evaluate the efficacy and safety of cetuximab combined with anti-PD-1 and mFOLFOX6 in the treatment of RAS/BRAF WT locally advanced or metastatic right colon cancer

Clinical Trial Description

According to the World Health Organization, colorectal cancer (CRC) is the third most common cancer in men and the second most common cancer in women worldwide. CRC is estimated to kill 551,269 patients worldwide each year, accounting for 5.8% of cancer deaths.Despite recent development in treatment, locally advanced or metastatic colon cancer (CC) represents a major therapeutic challenge. Presently, the standard therapeutic approach for CC is surgery and/or adjuvant chemotherapy. Nevertheless,several studies showed that neoadjuvant chemotherapy (NAC) is a more effective treatment option.Immune checkpoint inhibition (ICI) directed against programmed death-1 (PD-1) is highly effective and has become the standard of care for patients with dMMR metastatic colorectal cancers (mCRCs). In contrast, the same regimens have shown poor response rates in patients with pMMR mCRCs.Due to the high ORR rate of cetuximab combined with chemotherapy and the microenvironment with high immune infiltration of right colon cancer, it may be more sensitive to ICI. This study consisted of two phases: phase I consisted of 25 patients; if > 11 patients responded, the trial will continue to phase II, and a total of 66 patients will be enrolled. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05468177
Study type Interventional
Source Tongji Hospital
Contact Guihua Wang
Phone +86-027-83665215
Email ghwang@tjh.tjmu.edu.cn
Status Recruiting
Phase Phase 2
Start date August 1, 2022
Completion date June 30, 2025
View Details
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