drugset / Trial / NCT04509635

Cetuximab Re-challenge for Colorectal Cancer Liver Metastasis

NCT04509635

Phase 3 Unknown 50 enrolled Fudan University
RandomizedParallel-groupOpen-labelTreatment

Summary

For patients with unresectable colorectal cancer liver metastases, preclinical studies have shown that after the resistance of cetuximab, the treatment sensitivity can be restored by stopping cetuximab for a period of time. This is called the cetuximab re-challenge. And the circulating tumor DNA (ctDNA) test is reported a biomarker for the efficacy of cetuximab rechallenge. However, there is still no randomized controlled trial for verification. This study aims at patients after the first-line treatment of cetuximab has progressed. After the second-line non-cetuximab treatment has progressed, the effects of re-application of combined with cetuximab and chemotherapy alone are compared to verify the re-challenge effect.

Timeline

Start
2020-09-01
Primary completion
2022-08-31
Completion
2024-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody 500 mg/m2 Intravenous