Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT06959693
PHASE2/PHASE3

A Clinical Study to Evaluate the Efficacy and Safety of Envafolimab Combined With Cetuxima-βand mFOLFOX6 in Patients With MSS, RAS/BRAF Wild-Type Metastatic Colorectal Cancer (mCRC)

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

This is a prospective randomized controlled Phase Ⅱ/Ⅲ Clinical study to evaluate the clinical efficacy and safety of Envafolimab combining with Cetuximab -β and mFOLFOX6 in Patients With MSS, RAS/BRAF Wild-Type Metastatic Colorectal Cancer (mCRC)

Official title: mFOLFOX and Cetuximab - β With or Without Envafolimab for MSS, RAS/BRAF Wild - Type Advanced Unresectable CRC: Prospective, Randomized, Controlled Phase Ⅱ/Ⅲ Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

590

Start Date

2025-06-01

Completion Date

2030-06-30

Last Updated

2025-05-06

Healthy Volunteers

No

Interventions

DRUG

Cetuxima-β

500 mg/m², initial intravenous infusion (IV)\>120 min, subsequent IV \>60 min , D1,every 2 weeks

DRUG

Envafolimab

a single fixed dose of 200 mg, subcutaneous injection(SC), every 2 weeks (Day 1 of each cycle \[D1\])

DRUG

mFOLFOX6

Oxaliplatin 85 mg/m² , IV, over 120 min, Day 1; Leucovorin 400 mg/m² (or Calcium Folinate 200 mg/m²), IV, over 120 min, D1; 5-FU 400 mg/m² , bolus injection, followed by 1200 mg/(m²·d) continuous IV for 2 days (total dose 2400 mg/m² over 46 - 48 hours)

Locations (1)

Medical Oncology,Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China