Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06509009
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-05-23
Brief Title:
Nimotuzumab Combined With TGP as First-line Therapy in Patients With RecurrentMetastatic Nasopharyngeal Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Nimotuzumab Combined With ToripalimabGemcitabineCisplatin as First-line Therapy in Patients With RecurrentMetastatic Nasopharyngeal Carcinoma a Prospective Single-arm Phase II Clinical Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
The goal of this study is to learn the efficacy and safety of nimotuzumab combined with toripalimab and gemcitabinecisplatin regimen treatment recurrentdistant-metastasis nasopharyngeal carcinoma
Detailed Description:
The study is to investigate the efficacy and safety of combining nimotuzumab and toripalimab with the GP regimen for first line recurrentdistant metastasis nasopharyngeal carcinoma
This clinical trial adopts a single-center prospective single-arm phase II trial design Each treatment cycle will be three weeks long the chemotherapy regimen contains no more than 6 circles nimotuzumab and toripalimab were used until progression
After screening eligible patients will be enrolled in the study Patients will receive up to 6 cycles of nimotuzumab and toripalimab gemcitabine cisplatin therapy Patients will undergo regular follow-up visits and researchers will collect data on efficacy and safety Short-term outcomes will be assessed according to the RECIST 11 criteriairRECIST and adverse events will be evaluated using the CTCAE 50
This clinical trial adopts a single-center prospective single-arm phase II trial design Each treatment cycle will be three weeks long the chemotherapy regimen contains no more than 6 circles nimotuzumab and toripalimab were used until progression
After screening eligible patients will be enrolled in the study Patients will receive up to 6 cycles of nimotuzumab and toripalimab gemcitabine cisplatin therapy Patients will undergo regular follow-up visits and researchers will collect data on efficacy and safety Short-term outcomes will be assessed according to the RECIST 11 criteriairRECIST and adverse events will be evaluated using the CTCAE 50
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