Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2025-12-26 @ 10:40 AM
Study NCT ID:
NCT06569459
Status:
RECRUITING
Last Update Posted:
2024-08-26
First Post:
2024-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trilaciclib Combined With Concurrent Chemoradiotherapy and Immunotherapy in the Treatment of Esophageal Cancer
Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Organization:
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:
False
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?:
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?: