A Single-Arm, Phase II, Multicenter Clinical Study of Neoadjuvant Encorafenib Plus Cetuximab N01 and mFOLFOX6 in Patients With Locally Advanced BRAF V600E-Mutant Colorectal Cancer With or Without Resectable Metastases
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This is a single-arm, multicenter, phase II clinical trial evaluating the safety and efficacy of neoadjuvant encorafenib plus cetuximab N01 and mFOLFOX6 in patients with locally advanced BRAF V600E-mutated colorectal cancer, with or without resectable metastases. Eligible patients will receive 8 weeks of neoadjuvant treatment with encorafenib, cetuximab N01, and mFOLFOX6, followed by tumor response assessment and radical surgery when appropriate. The primary endpoint is 18-month disease-free survival (DFS). Secondary endpoints include perioperative safety, objective response rate, pathological response rate, 1-year DFS, 3-year DFS, overall safety, and quality of life. This study aims to explore whether incorporating BRAF and EGFR targeted therapy into standard chemotherapy in the neoadjuvant setting can improve tumor control and long-term outcomes in this high-risk molecular subgroup of colorectal cancer.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18-75 lat w dobrym stanie ogólnym
- •Potwierdzony histopatologicznie rak gruczołowy jelita grubego
- •Nowotwór zaawansowany lokalnie, niekwalifikujący się wcześniej do leczenia, lub przerzuty dające się całkowicie usunąć chirurgicznie
- •Mutacja BRAF V600E oraz brak mutacji w genach KRAS i NRAS
- •Prawidłowe funkcje wątroby, nerek i krwawienia
- •Wystarczająca liczba krwinek (hemoglobina, neutrofile, płytki) oraz prawidłowe wyniki biochemiczne
- •Prawidłowa funkcja tarczycy
- •Dobrowolna zgodę na uczestnictwo i podpisany formularz świadomej zgody
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Last updated (source)
- August 27, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
Trial contact
Kefeng Ding
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/28/2026.
You can help another person
We fund the Radar, this site, and the development of our Grosz dla Życia fundraising platform from donations and our own resources. Every contribution, even a small one, really helps.