Ignite Creation Date:
2024-07-17 @ 11:14 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06486220
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-21
Brief Title:
PFLL Combined With PD-1 Antibody With or Without FMT for Oligometastatic NPCa Phase III Open Randomized Clinical Trial
Sponsor:
Yun-fei Xia
Organization:
Sun Yat-sen University
Study Overview
Official Title:
PFLL Combined With PD-1 Antibody With or Without FMT for Oligometastatic NPCa Phase III Open Randomized Clinical Trial
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:
There is a correlation between gut microbiota and immunotherapy reactivity and regulating gut microbiota through FMT can prevent primary resistance to immune checkpoint inhibitors and further improve the effectiveness of tumor immunotherapyTherefore on the basis of previous studies this study intends to explore whether intestinal flora transplantation can improve the anti-tumor efficacy of low-dose long term 5-FU pumping old fire soup therapy combined with immunotherapy and reduce the occurrence of toxic side effects in patients with metastatic nasopharyngeal carcinoma
Detailed Description:
Experimental group PFLL PD-1 FMT
5-Fu 200mg m2 d D1-30 cisplatin 80mg m2 d1 28 or D1-3 28-30 triplizumab 240mg d1 22 FMT 10 capsules in the morning middle and evening D-5-3 11-13 38-40Every 60 dayscycle PFLL PD-1 FMT is given for a maximum of 6 cycles
Control group PFLL PD-1
5-Fu 200mg m2 d D1-30 cisplatin 80mg m2 d1 28 or D1-3 28-30 triplizumab 240mg d1 22PFLL PD-1 is given a maximum of 6 cycles per 60 dayscycle
5-Fu 200mg m2 d D1-30 cisplatin 80mg m2 d1 28 or D1-3 28-30 triplizumab 240mg d1 22 FMT 10 capsules in the morning middle and evening D-5-3 11-13 38-40Every 60 dayscycle PFLL PD-1 FMT is given for a maximum of 6 cycles
Control group PFLL PD-1
5-Fu 200mg m2 d D1-30 cisplatin 80mg m2 d1 28 or D1-3 28-30 triplizumab 240mg d1 22PFLL PD-1 is given a maximum of 6 cycles per 60 dayscycle
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