Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-31 @ 5:13 PM
Study NCT ID:
NCT04146402
Status:
UNKNOWN
Last Update Posted:
2020-02-05
First Post:
2019-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SCT-I10A Plus Standard Chemotherapy in First-line Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma
Sponsor:
Sinocelltech Ltd.
Organization:
Study Overview
Official Title:
SCT-I10A Combined With Standard Chemotherapy Versus Placebo Combined With Standard Chemotherapy in First-line Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC): A Phase III, Multicenter, Randomized, Double-blinded Trial
Status:
UNKNOWN
Status Verified Date:
2020-02
Last Known Status:
RECRUITING
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:
The objective of this study is to evaluate the efficacy and safety of SCT-I10A plus standard chemotherapy for Recurrent/ Metastatic Head and Neck Squamous cell Carcinoma
Detailed Description:
This is a Phase III, multicenter, randomized, double-blinded trial designed to evaluate Overall survival (OS) of SCT-I10A combined with standard chemotherapy in patients living with Recurrent/ Metastatic Head and Neck Squamous cell Carcinoma
Study Oversight
Has Oversight DMC:
None
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?: