Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04830267
Status:
RECRUITING
Last Update Posted:
2024-03-28
First Post:
2021-03-31
Brief Title:
The Efficacy of Camrelizumab Plus Stereotactic Body Radiotherapy in RM NPC
Sponsor:
Chongqing University Cancer Hospital
Organization:
Chongqing University Cancer Hospital
Study Overview
Official Title:
A Phase II Randomized Trial of Camrelizumab With Stereotactic Body Radiotherapy Versus Camrelizumab Alone in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
Status:
RECRUITING
Status Verified Date:
2024-03
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:
Camrelizumab is an antibody targeting programmed death receptor 1 PD-1 and its ligand programmed death-ligand 1 PD- L1 that is designed to boost the immune system It does this by allowing immune cells to fight the cancer Stereotactic body radiotherapy is a potential immunostimulatory therapy that may amplify antitumor response when combined with camrelizumab
Detailed Description:
All eligible patients from 3 hospitals will be equally randomized between the 2 following treatment groups
Standard treatment group Camrelizumab 200mg IV every 2 weeks Experimental group Stereotactic body radiotherapy 27Gy3F and Camrelizumab 200mg IV every 2 weeks
Standard treatment group Camrelizumab 200mg IV every 2 weeks Experimental group Stereotactic body radiotherapy 27Gy3F and Camrelizumab 200mg IV every 2 weeks
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?:
None