Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06161909
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-08
First Post:
2023-11-22
Brief Title:
Postoperative Immune Maintenance Therapy for Esophageal Squamous Cell Carcinoma After Radical Resection
Sponsor:
Fujian Medical University Union Hospital
Organization:
Fujian Medical University Union Hospital
Study Overview
Official Title:
Postoperative Adjuvant Immune Maintenance Therapy for High Recurrence Risk Esophageal Squamous Cell Carcinoma After Radical Resection a Multicenter Randomized Controlled Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
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:
Esophageal cancer EC is one of the most common malignant tumors of the digestive tract in human beings Most cases of EC are initially diagnosed in an advanced stage of the disease Considering the lack of effective adjuvant therapies after surgery for locally advanced esophageal squamous carcinoma And with the encouraging preliminary results of PD-1 inhibitors in advanced esophageal squamous cell carcinoma ESCC postoperative adjuvant immunotherapy for esophageal squamous carcinoma seems to be feasible The main objective of this study was the efficacy of postoperative adjuvant therapy with sintilimab in patients with ESCC radically resected after neoadjuvant chemoimmunotherapy
Detailed Description:
sophageal cancer EC is one of the most common malignant tumors of the digestive tract in human beings Most cases of EC are initially diagnosed in an advanced stage of the disease Considering the lack of effective adjuvant therapies after surgery for locally advanced esophageal squamous carcinoma And with the encouraging preliminary results of PD-1 inhibitors in advanced esophageal squamous cell carcinoma ESCC postoperative adjuvant immunotherapy for esophageal squamous carcinoma seems to be feasible The main objective of this study was the efficacy of postoperative adjuvant therapy with sintilimab in patients with ESCC radically resected after neoadjuvant chemoimmunotherapy
All participants who meet the inclusion criteria will be enrolled after signing the informed consent form A total of 400 patients are to be recruited for the study 400 subjects were randomly assigned to the two treatment groups Group A Postoperative adjuvant sintilimab 200mg fixed dose Q3W immunotherapy will be administered for a total of 1 year Group B Close observation The primary endpoint is disease-free survival DFS The secondary endpoints are postoperative overall survival OS 1 2 and 3-year postoperative OS rates recurrent metastasis pattern local recurrence or distant metastasis
All participants who meet the inclusion criteria will be enrolled after signing the informed consent form A total of 400 patients are to be recruited for the study 400 subjects were randomly assigned to the two treatment groups Group A Postoperative adjuvant sintilimab 200mg fixed dose Q3W immunotherapy will be administered for a total of 1 year Group B Close observation The primary endpoint is disease-free survival DFS The secondary endpoints are postoperative overall survival OS 1 2 and 3-year postoperative OS rates recurrent metastasis pattern local recurrence or distant metastasis
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