Ignite Creation Date:
2024-07-17 @ 10:51 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06472713
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-15
Brief Title:
Clinical Study of Mitoxantrone Hydrochloride Liposome Combined With PD-1 Blockade in Recurrent or Metastatic NPC
Sponsor:
Ming-Yuan Chen
Organization:
Sun Yat-sen University
Study Overview
Official Title:
A Prospective Single-arm Phase 2 Study Evaluating the Efficacy and Safety of Mitoxantrone Hydrochloride Liposome Injection Combined With PD-1 Blockade in Previously Treated Recurrent or Metastatic Nasopharyngeal Carcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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 a prospective single-arm Phase 2 study to evaluate the efficacy and safety of mitoxantrone hydrochloride liposome injection combined with PD-1 blockade in patients with recurrent not unable to locally curative treatment or metastatic NPC who failed at least first-line platinum-containing standard regimen andor anti PD-1L1
Detailed Description:
Thirty-two recurrent not unable to locally curative treatment or metastatic NPC patients who had failed at least first-line platinum-containing standard regimen andor anti PD-1L1 were eligible to receive mitoxantrone hydrochloride liposome injection combined with PD-1 blockade once every 3 weeks for up to 8 cycles following PD-1 blockade alone once every 3 weeks for 2 years 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?:
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