Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06163729
Status:
RECRUITING
Last Update Posted:
2024-02-02
First Post:
2023-12-01
Brief Title:
Camrelizumab Combined With Chemotherapy and Radiotherapy Perioperative Treatment of Esophageal Gastric Junction Adenocarcinoma
Sponsor:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Organization:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Study Overview
Official Title:
A Single-arm Multicenter Phase II Clinical Study of Camrelizumab Combined With Chemotherapy Followed by Radiotherapy in the Perioperative Treatment of Gastroesophageal Junction Adenocarcinoma
Status:
RECRUITING
Status Verified Date:
2023-12
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 project intends to study the efficacy and safety of camrelizumab combined with chemotherapy followed by radiotherapy in the perioperative treatment of AEG
Detailed Description:
The incidence of Adenocarcinoma of esophagogastric junction AEG is increasing in recent years According to the statistics of The National Cancer Center of Japan the proportion of AEG in gastric adenocarcinoma increased from 23 in the middle of the 20th century to 103 in the beginning of this century and the proportion of Siewert II in AEG increased from 285 to 573 Due to the special biological characteristics of tumor in this region its definition and surgical treatment principles are controversial
For AEG the clinical study results of neoadjuvant chemoradiotherapy surgery chemotherapy showed that the tumor stage could be reduced R0 resection could be improved and overall survival could be improved without increasing postoperative complications and mortality Long-term follow-up results from the German TRIAL III of preoperative chemoradiotherapy for AEG POET showed that preoperative chemoradiotherapy reduced recurrence 5y-local recurrence 21 vs 38 and prolonged survival 3y-OS 467 vs 261 without a significant increase in treatment toxicity and perioperative complications Although some patients with AEG were included in the resolve prodigy and resolution study and the total population could benefit from postoperative adjuvant radiotherapy and chemotherapy but it was uncertain whether the patients with AEG could benefit in Asia
Therefore this project intends to study the efficacy and safety of camrelizumab combined with chemotherapy followed by radiotherapy in the perioperative treatment of AEG
For AEG the clinical study results of neoadjuvant chemoradiotherapy surgery chemotherapy showed that the tumor stage could be reduced R0 resection could be improved and overall survival could be improved without increasing postoperative complications and mortality Long-term follow-up results from the German TRIAL III of preoperative chemoradiotherapy for AEG POET showed that preoperative chemoradiotherapy reduced recurrence 5y-local recurrence 21 vs 38 and prolonged survival 3y-OS 467 vs 261 without a significant increase in treatment toxicity and perioperative complications Although some patients with AEG were included in the resolve prodigy and resolution study and the total population could benefit from postoperative adjuvant radiotherapy and chemotherapy but it was uncertain whether the patients with AEG could benefit in Asia
Therefore this project intends to study the efficacy and safety of camrelizumab combined with chemotherapy followed by radiotherapy in the perioperative treatment of AEG
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