NCT04718038

Continuing Cetuximab Plus Chemotherapy After First Progression in Wild-type KRAS, NRAS and BRAF V600E Metastatic Colorectal Cancer

A Clinical Study of Continuing Cetuximab Plus Chemotherapy After First Progression in Wild-type KRAS, NRAS and BRAF V600E Metastatic Colorectal Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The aim of this study was to evaluate the efficacy and safety of continuing cetuximab combined with chemotherapy after first-line progression in wild-type KRAS,NRAS and BRAF colorectal cancer.

Detailed description

In addition to the sequential therapeutic schedule of offering maintenance therapy and reintroduction of chemotherapy regimens to patients with nonresectable mCRC, multiline treatment strategy of continuing bevacizumab after progression to first-line bevacizumab plus chemotherapy demonstrated optimal clinical benefits in prolonging progression-free survival (PFS) and overall survival (OS) . Continuing cetuximab after progression to first-line cetuximab is also a promising strategy. The underlying hypothesis is that a sustained inhibition of EGFR signaling with cetuximab would continuously eliminate sensitive clones of RAS wild-type tumor. The present phase 2 clinical trial evaluated standard fluoropyrimidine-based chemotherapy combined with cetuximab among patients with wild-type KRAS, NRAS and BRAF V600E mCRC who had progressed after cetuximab plus standard chemotherapy in the first-line setting.

Conditions

• Wild-type KRAS,NRAS and BRAF V600E Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Cetuximab combind mFOLFOX6/FOLFIRI	Cetuximab 500mg/m2 ivgtt 2h d1 ,q14d;mFOLFOX6: Oxaliplatin 85mg/m2 ivgtt 2h d1, 5-Fu 400mg/m2 iv d1,Lefucovorin 400mg/m2 ivgtt 2h d1, 5-Fu 2.4/m2 CIV 46h, q14d; FOLFIRI: CPT-11 180mg/m2 ivgtt 60-90mins d1, 5-Fu 400mg/m2 iv d1,Lefucovorin 400mg/m2 ivgtt 2h d1,5-Fu 2.4/m2 CIV 46-48h, q14d

Timeline

• Start date: 2016-07-01
• Primary completion: 2018-02-01
• Completion: 2020-09-01
• First posted: 2021-01-22
• Last updated: 2021-01-22