Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06632405
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
A Trial of Camrelizumab Plus Nab-paclitaxel and Levocetirizine in Metastatic or Recurrent TNBC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Camrelizumab Plus Nab-paclitaxel and Anti-histamine Drug Levocetirizine in Metastatic or Recurrent Triple-negative Breast Cancer a Randomized Double-arm Phase 2 Randomized Controlled Trial
Status:
NOT_YET_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 phase II open-labeled multi-centered double-arm investigator-initiated clinical trial of Camrelizumab an anti-PD-1 antibody in combination with Nab-paclitaxel a chemotherapeutic agent against breast cancer and Levocetirizine an antihistamine in patients with advanced triple-negative breast cancer 60 subjects will be enrolled in multiple centers This study aims to evaluate the effects of Camrelizumab combined with Nab-paclitaxel and Levocetirizine in the treatment of advanced TNBC
Detailed Description:
This is a phase II open-labeled multi-centered double-arm investigator-initiated clinical trial to evaluate the effects of Camrelizumab combined with Nab-paclitaxel and Levocetirizine in the treatment of advanced TNBC The study aims to enroll 60 subjects in multiple centers The primary objective is to assess the overall response rate ORR All enrolled patients will be treated with Camrelizumab 200mg iv 3mgkg for patient whose weight is below 50kg on day 1 of each 3 week and Nab-paclitaxel 100mgm2 iv on d1815 of each 4 week in combination with Levocetirizine of 5mg po 3 days before 1st administration
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