NCT05468177

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Colonic Neoplasms

Interventions

Type	Name	Description
COMBINATION_PRODUCT	neoadjuvant chemotherapy	Cetuximab: 500mg/m2,day1, every 2 weeks. mFOLFOX: oxaliplatin 85mg/m2, day 1;LV 400mg/m2, day 1;5-FU 400mg/m2, day 1, then 1200mg/ (m2•d) ×2days(total 2400mg/m2, infusion 46-48h) (every 2 weeks). Anti-PD-1(Sintilimab Injection):200mg every 3 weeks. Surgery will be performed after 4 cycles for locally advanced or initially resectable metastatic right colon cancer.If the initial unresectable metastatic right colon cancer were converted into resectable metastases, and surgery will be performed. Patients who failed to convert after 6 cycles of treatment will be withdrawn from the study.Cetuximab +mFOLFOX was treat for 8 cycles, and Anti-PD-1 was treated for one year in the perioperation period unless disease progression, toxicity intolerance, initiation of new anti-tumor therapy.

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-06-30
• Completion: 2025-06-30
• First posted: 2022-07-21
• Last updated: 2022-07-21

Locations

1 site across 1 country: China