Ignite Creation Date:
2024-05-06 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05790447
Status:
RECRUITING
Last Update Posted:
2023-03-30
First Post:
2023-03-09
Brief Title:
Thymalfasin-based PRaG Mode for Advanced Refractory Solid Tumors
Sponsor:
Second Affiliated Hospital of Soochow University
Organization:
Second Affiliated Hospital of Soochow University
Study Overview
Official Title:
Treatment of Advanced Refractory Solid Tumors Based on Precise Thymalfasin-regulated PRaG Mode an Open-label Prospective Multicenter Study PRaG 50 Study
Status:
RECRUITING
Status Verified Date:
2023-03
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:
This is an open-label single-arm Phase II investigator-initiated trial of precise thymalfasin-regulated therapy combined with hypofractionated radiotherapy PD-1PD-L1 inhibitor sequential GM-CSF for treatment of advanced refractory solid tumors
Detailed Description:
One cycle of activation cycle includes Loading dose with thymalfasin was administrated based on the absolute number of T lymphocytes
Radiotherapy 5 or 8Gy three fractionswas administrated to a metastatic lesion
GM-CSF 200ug was subcutaneous injected for seven days from the first day of radiotherapy PD-1L1 inhibitor was intravenous injected within one week after radiotherapy
At least two activation cycles were administrated Then maintenance treatment includes Loading dose with thymalfasin was administrated based on the absolute number of T lymphocytes
GM-CSF 200ug was subcutaneous injected for seven days PD-1L1 inhibitor was intravenous injected
Radiotherapy 5 or 8Gy three fractionswas administrated to a metastatic lesion
GM-CSF 200ug was subcutaneous injected for seven days from the first day of radiotherapy PD-1L1 inhibitor was intravenous injected within one week after radiotherapy
At least two activation cycles were administrated Then maintenance treatment includes Loading dose with thymalfasin was administrated based on the absolute number of T lymphocytes
GM-CSF 200ug was subcutaneous injected for seven days PD-1L1 inhibitor was intravenous injected
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