Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07789210
PHASE2

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

Sponsor: Zhejiang University

View on ClinicalTrials.gov

Summary

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.

Official title: Neoadjuvant Encorafenib, Cetuximab N01 and mFolfox6 for BRAF V600E Mutated/ pMMR Localized Colorectal Cancer With or Without Resectable Metastases: a Single Arm, Multi-center, Phase 2 Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2026-06-30

Completion Date

2031-06-30

Last Updated

2026-08-27

Healthy Volunteers

No

Interventions

DRUG

Neoadjuvant therapy of encorafenib plus cetuximab N01 and mFOLFOX6

Eligible subjects will receive neoadjuvant therapy comprising mFOLFOX6 (oxalipatin 130mg/m², IV + 5-Fu 2400 mg/m², IV, q2w), encorafenib (300mg, qd, po, d1-28) and cetuximab N01 (500 mg/m², IV, q2w) for two months

Locations (1)

Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China