Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05964101
Status:
RECRUITING
Last Update Posted:
2024-05-21
First Post:
2023-07-12
Brief Title:
Nivolumab Combined With Chemotherapy in the Treatment of Primary Tracheal Squamous Cell Carcinoma
Sponsor:
The First Affiliated Hospital of Guangzhou Medical University
Organization:
The First Affiliated Hospital of Guangzhou Medical University
Study Overview
Official Title:
Neoadjuvant Anti-PD-1 Drug Nivolumab Combined With Chemotherapy in the Treatment of Primary Tracheal Squamous Cell Carcinoma
Status:
RECRUITING
Status Verified Date:
2024-05
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:
GALAXY-1
Brief Summary:
This is a single-arm open II phase study to evaluate the safety and efficacy of Nivolumab carboplatin paclitaxel in 25 newly diagnosed patients with primary tracheal squamous cell carcinoma
Detailed Description:
Primary tracheal tumors are rare comprising 001-04 of all cancer cases Most airway tumors present with non-specific symptoms such as shortness of breath and a sore throat which may not be attributable to the tumors themselves leading to diagnostic delay With limited treatment options surgical resection is considered the cornerstone therapy Neoadjuvant therapy is recommended as standard treatment for the early stages stage IBII and locally advanced stages stage IIIA of non-small cell lung cancer NSCLC Whether neoadjuvant therapy affects subsequent pathological or surgical outcomes of primary tracheal tumors remains unclear This study aimed to characterize the outcomes of neoadjuvant therapy for the treatment of primary tracheal squamous cell carcinoma
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?:
False
Is an FDA AA801 Violation?:
None