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

NCT05775900 PHASE1, PHASE2 COMPLETED

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.

Details

Lead sponsor	Sun Yat-sen University
Phase	PHASE1, PHASE2
Status	COMPLETED
Enrolment	24
Start date	Wed Feb 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Tue Aug 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Metastatic Colorectal Cancer

Interventions

• Cetuximab
• Capecitabine

Countries

China