NCT05775900

Efficacy and Safety of Triweekly Cetuximab in Combination With Capecitabine as First-line Maintenance Treatment for KRAS/BRAF Wild-type Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To explore the safety, efficacy and pharmacokinetic (PK) characteristics of triweekly cetuximab in combination with capecitabine as first-line maintenance treatment for KRAS/BRAF wild-type metastatic colorectal cancer: a single-arm, a single-center, Phase 1b trial. Meanwhile, Exploring the maximum tolerant dose or recommended II research dose of triweekly cetuximab combined with a fixed dose of capecitabine using '3+3' dose climbing Phase I experiment.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Cetuximab	Cetuximab will be given triweekly at a dose from 400mg/m2 to 700mg/m2.
DRUG	Capecitabine	Capecitabine will be given 2 weeks on/1 week off (1000mg/m2 BID po.)

Timeline

• Start date: 2023-02-01
• Primary completion: 2025-07-31
• Completion: 2025-08-26
• First posted: 2023-03-20
• Last updated: 2025-09-03

Locations

1 site across 1 country: China