Ignite Creation Date:
2024-05-06 @ 5:39 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05387681
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-05-24
First Post:
2022-05-12
Brief Title:
Preoperative Short Course Radiotherapy With Envafolimab Endostatin and SOX Regimen in Locally Advanced Gastric
Sponsor:
Wuhan Union Hospital China
Organization:
Wuhan Union Hospital China
Study Overview
Official Title:
An Exploratory Clinical Study of Short-course Radiotherapy Combined With Envafolimab Endostatin and SOX Regimen for Neoadjuvant Treatment of Resectable Locally Advanced GastricGastroesophageal Junction Adenocarcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-05
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:
None
Brief Summary:
This is a single-arm exploratory clinical study to evaluate the efficacy and safety of Preoperative short course radiotherapy with Envafolimab Endostatin and SOX regimen in resectable locally advanced gastricgastroesophageal junction adenocarcinoma
Detailed Description:
All eligible subjects will receive 55Gy 25Gy5F fractionated radiotherapy rest for 1 week 3 cycles of Envafolimab Endostatin and SOX regimen and radical surgery 2 to 4 weeks after completion of the last neoadjuvant therapy according to the study plan Each patient will be followed up 12 months after initiation of treatment in the study Whether the subjects need adjuvant therapy after surgery and the adjuvant treatment plan are determined by the investigator All subjects were required to complete the study follow-up plan after surgery
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