Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06657690
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-23
Brief Title:
Irinotecan Liposome Combined with S-1 in PD-1L1 Inhibitor Refractory Recurrent or Metastatic NPC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Efficacy and Safety of Irinotecan Liposome Combined with S-1 in PD-1L1 Inhibitor Refractory Recurrent or Metastatic Nasopharyngeal Carcinoma a Prospective Single-arm Phase 2 Study
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective single-arm Phase 2 study to evaluate the efficacy and safety of Irinotecan Liposome injection combined with S-1 in patients with recurrent unable to local curative treatment or metastatic NPC who failed at least first-line anti-PD-1L1
Detailed Description:
Fifty-six recurrent unable to local curative treatment or metastatic NPC patients who had failed at least first-line anti-PD-1L1 whether or not combined with chemotherapy were eligible to receive Irinotecan Liposome injection combined with S-1 for up to 6 cycles All patients will be treated until disease progression as determined by the investigator based on RECIST 11 criteria intolerable toxicity subject withdrawal of informed consent initiation of new antitumor therapy loss of follow-up death or study completion whichever occurs first Regular visits and imaging examinations will be conducted to evaluate the efficacy and safety of the treatment regimen
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None