Ignite Creation Date:
2024-05-06 @ 3:27 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04631757
Status:
UNKNOWN
Last Update Posted:
2020-11-17
First Post:
2020-11-15
Brief Title:
Conversion Therapy of Camrelizumab Plus Chemoradiotherapy in Participants With Initial Unresectable Gastric or Gastroesophageal Junction GEJ Adenocarcinoma
Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Organization:
Tianjin Medical University Cancer Institute and Hospital
Study Overview
Official Title:
A Prospective Non-randomized Phase II Study of Camrelizumab in Combination With Concurrent Chemoradiotherapy for Initial Unresectable Proximal Gastric or Gastroesophageal Junction GEJ Adenocarcinoma Conversion Therapy
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
NOT_YET_RECRUITING
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 study of Camrelizumab in Combination With concurrent radiotherapy and SOX for Initial Unresectable or potentially resectable proximal Gastric or Gastroesophageal Junction GEJ Adenocarcinoma Patients without prior palliative therapy will be treated with Camrelizumab radiotherapy total 45 Gy Oxaliplatin and S-1 The primary endpoint is the 1-year PFS rate
Detailed Description:
The purpose of this study is to evaluate the efficacy and safety of Camrelizumab plus Concomitant Chemoradiotherapy in patients with Initial Unresectable or potentially resectable proximal Gastric or Gastroesophageal Junction GEJ Adenocarcinoma 33 participants with Initial Unresectable locally advanced proximal gastric carcinoma Gastroesophageal Junction GEJ Adenocarcinoma Siewert type IIIII will be treated with conversion therapy as below once recruited
1 induction chemotherapy 3w one cycle of camrelizumab 200mg q3w and SOX regimen oxaliplatin 130mgm2 d1 Q3w S-1 40-60mg bid d1-d14Q3w
2 after the induction concurrent Chemoradiotherapy will be started 5-6w intensity modulated radiotherapy was given for tumors and high-risk lymphatic drainage areas total dose45Gy25d 18Gyd camrelizumab 200mg q3w S-1 40-60mg bid d1-d14 Q3w The resectability assessment will be performed followed by MDT
3 Participants still unresectable will receive additional conversion therapy with camrelizumab and SOX regimen The resectability will be evaluated every 6 weeks until resectable or up to 8 cycles of conversion therapy
Resectable patients will receive D2 resection
1 induction chemotherapy 3w one cycle of camrelizumab 200mg q3w and SOX regimen oxaliplatin 130mgm2 d1 Q3w S-1 40-60mg bid d1-d14Q3w
2 after the induction concurrent Chemoradiotherapy will be started 5-6w intensity modulated radiotherapy was given for tumors and high-risk lymphatic drainage areas total dose45Gy25d 18Gyd camrelizumab 200mg q3w S-1 40-60mg bid d1-d14 Q3w The resectability assessment will be performed followed by MDT
3 Participants still unresectable will receive additional conversion therapy with camrelizumab and SOX regimen The resectability will be evaluated every 6 weeks until resectable or up to 8 cycles of conversion therapy
Resectable patients will receive D2 resection
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