NCT07000305

A Study of Cetuximabβ Combined With Envolimab and mFOLFOX6 in Subjects With Advanced Colorectal Cancer

Cetuximabβ Combined With Envolimab and mFOLFOX6 as First-line Treatment for RAS/BRAF Wild-type, MSS, Unresectable , Metastatic Colorectal Cancer: A Single-arm, Multi-center, Phase II Trail

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Tao Zhang · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A study of Cetuximabβ combined with Envolimab and mFOLFOX6 in Subjects with Advanced Colorectal Cancer

Conditions

• Advanced Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Cetuximabβ combined with Envolimab and mFOLFOX6	Envolimab, 200 mg, sc, day 1; Cetuximabβ 500 mg/m2 IV over 60- 120 min, day 1; chemotherapy mFOLFOX6; with the above regimen every 14 days for 1 treatment cycle. Then patients who did not experience disease progression within 8-12 cycles were entered into maintenance therapy, which consisted of a fluorouracil-based-chemotherapy with Cetuximabβ and Envolimab regimen until progression or unacceptable toxicity.

Timeline

• Start date: 2025-05-20
• Primary completion: 2027-05-20
• Completion: 2028-05-20
• First posted: 2025-06-02
• Last updated: 2025-06-02

Locations

1 site across 1 country: China