Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05807880
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-06
First Post:
2023-03-28
Brief Title:
Anlotinib Penpulimab and Capecitabine in RecurrentMetastatic Nasopharyngeal Carcinoma
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
The First-line Therapy With the Combination of Anlotinib Penpulimab and Capecitabine in RecurrentMetastatic Nasopharyngeal Carcinoma a Single-arm Open-label Phase II Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
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:
ALTER-HN005
Brief Summary:
First-diagnosed metastasis or recurrencemetastasis NPC Patients will be treated with anlotinib penpulimab and capecitabine
Detailed Description:
The trial is an open-label single-arm phase II clinical trial This trial plans to enroll patient that is diagnosed with locoregionally advanced nasopharyngeal carcinoma at hisher first diagnosis and has recurrencemetastasis at least 6 months after completing radiotherapy and chemotherapy for the primary lesion and has never accepted systemic treatment for recurrentmetastatic lesion before The first-line treatment is the three-drug treatment plan including anlotinib penpulimab and capecitabine for 4-6 cycles Then a maintenance treatment will be run including penpulimab and capecitabine until PD or intolerance to toxicity
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