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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

NCT05775900 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-09-03

No results posted yet for this study

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

Interventions

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.)

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Yanhong Deng, Ph.D · Sixth Affiliated Hospital, Sun Yat-sen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2025-07-31
Completion
2025-08-26

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05775900 on ClinicalTrials.gov