Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT05959356
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2023-07-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cetuximab and Envafolimab Plus mFOLFOXIRI as First-line Treatment for RAS/BRAF Wild-type, MSS, Unresectable Left-side Metastatic Colorectal Cancer
Sponsor:
Sun Yat-sen University
Organization:
Study Overview
Official Title:
Cetuximab and Envafolimab Plus mFOLFOXIRI Versus Cetuximab Plus mFOLFOX6 as First-line Treatment for RAS/BRAF Wild-type, MSS, Unresectable Left-side Metastatic Colorectal Cancer: A Randomized Controlled Phase II Trial (CEIL)
Status:
RECRUITING
Status Verified Date:
2025-11
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:
CEIL
Brief Summary:
The primary aim of phase II CEIL study is to evaluate the efficacy of cetuximab and envafolimab plus mFOLFOXIRI versus cetuximab plus mFOLFOX6 as first line treatment of patients with initially unresectable and previously untreated RAS/BRAF wild-type, MSS, left-side metastatic colorectal cancer(mCRC), in terms of Progression-free Survival.
Detailed Description:
This is a prospective, open-label, multi-center, randomized controlled phase II trial in which patients with initially unresectable and previously untreated RAS/BRAF wild-type, MSS, left-side mCRC will be randomized to two therapy groups:
Experimental arm A: receive induction treatment with cetuximab and envafolimab plus mFOLFOXIRI up to 8 cycles followed by maintenance with cetuximab and envafolimab plus 5-FU/LV until disease progression, unacceptable toxicity or patient's refusal.
Standard arm B: receive induction treatment with cetuximab plus mFOLFOX6 up to 8 cycles followed by maintenance with cetuximab plus 5-FU/LV until disease progression, unacceptable toxicity or patient's refusal.
The second- and subsequent lines of treatment will be at investigators' choice.
Experimental arm A: receive induction treatment with cetuximab and envafolimab plus mFOLFOXIRI up to 8 cycles followed by maintenance with cetuximab and envafolimab plus 5-FU/LV until disease progression, unacceptable toxicity or patient's refusal.
Standard arm B: receive induction treatment with cetuximab plus mFOLFOX6 up to 8 cycles followed by maintenance with cetuximab plus 5-FU/LV until disease progression, unacceptable toxicity or patient's refusal.
The second- and subsequent lines of treatment will be at investigators' choice.
Study Oversight
Has Oversight DMC:
False
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?:
None
Is an FDA AA801 Violation?: