Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06569459
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
Trilaciclib Combined With Concurrent Chemoradiotherapy and Immunotherapy in the Treatment of Esophageal Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Randomized Controlled Single-center Phase II Clinical Trial of Trilaciclib Combined With Concurrent Chemoradiotherapy and Immunotherapy for Locally Advanced Esophageal Cancer
Status:
RECRUITING
Status Verified Date:
2024-08
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 study is a double-arm randomized controlled single-center phase II clinical trial aimed at evaluating the efficacy and safety of chemoradiotherapy plus immunotherapy with or without Trilaciclib in the treatment of locally advanced esophageal squamous cell carcinoma that is not resectable
Detailed Description:
The subjects included in the study will receive Trilaciclib combined with chemoradiotherapy and immunosuppressant group the experimental group and chemoradiotherapy combined with immunosuppressant group the control group The experimental group and the control group were treated with 4 cycles of treatment If the efficacy was evaluated as non-progressive after 4 cycles of treatment the experimental group and the control group continued immunosuppressive therapy until disease progression or intolerance The incidence of grade 3 neutropenia during chemotherapy was used as the primary endpoint
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