CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
Cetuximab +1 moredrug
Likely dose
Cetuximab 400mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05775900
NCT05775900Phase 2Completed
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Efficacy and Safety of Triweekly Cetuximab in Combination With Capecitabine as First-line Maintenance Treatment for KRAS/BRAF Wild-type Metastatic Colorectal Cancer

Sun Yat-sen University·interventional·Posted Mar 20, 2023·Updated Sep 3, 2025

In Brief

A Phase 2 clinical trial evaluating Cetuximab and Capecitabine for Metastatic Colorectal Cancer. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Colorectal Cancer
CountriesChina
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedMar 20, 2023
Enrollment StartFeb 1, 2023
Primary CompletionJul 31, 2025
Study CompletionAug 26, 2025
TodayJul 1, 2026
Enrollment to primary: 2.5 yearsPosted 3.3 years ago

Interventions

Cetuximabdrug

Cetuximab will be given triweekly at a dose from 400mg/m2 to 700mg/m2.

Capecitabinedrug

Capecitabine will be given 2 weeks on/1 week off (1000mg/m2 BID po.)