Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2026-01-01 @ 10:30 AM
Study NCT ID:
NCT06959693
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-06
First Post:
2025-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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)
Detailed Description:
Patients diagnosed with unresectable, microsatellite - stable (MSS), RAS/BRAF wild - type metastatic colorectal adenocarcinoma who have not received prior systemic anti-neoplastic therapy for metastatic or recurrent lesions will be included in this study.
In the Phase II study, approximately 186 patients will be enrolled, with 93 assigned to the experimental group and 93 to the control group. In the Phase III study, around 404 patients will be recruited, with 202 allocated to the experimental group and 202 to the control group.
Eligible patients will undergo a screening period of up to 28 days, followed by a treatment period consisting of 2 - week cycles for a maximum duration of 2 years. Subsequently, a follow - up period will be implemented, which includes a safety follow - up and survival follow - ups conducted every 12 weeks.
In the Phase II study, approximately 186 patients will be enrolled, with 93 assigned to the experimental group and 93 to the control group. In the Phase III study, around 404 patients will be recruited, with 202 allocated to the experimental group and 202 to the control group.
Eligible patients will undergo a screening period of up to 28 days, followed by a treatment period consisting of 2 - week cycles for a maximum duration of 2 years. Subsequently, a follow - up period will be implemented, which includes a safety follow - up and survival follow - ups conducted every 12 weeks.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: