Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06597227
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
Proximal Gastrectomy Vs Total Gastrectomy in Locally Advanced Upper Gastric Cancer After Neoadjuvant Therapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of Clinical Efficacy of Proximal Gastrectomy Vs Total Gastrectomy in Locally Advanced Upper Gastric Cancer After SOX Combined with Anti-PD-1 Neoadjuvant Therapya Prospective Multi-center Randomisedcontrolled Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TJHGC01
Brief Summary:
We plan to evaluate the efficacy and safety of proximal gastric vs total gastric radical resection after SOX combined with anti-PD-1 neoadjuvant therapy in locally advanced upper gastric cancer
Detailed Description:
Gastric cancer is one of the most common malignant tumors in China and its morbidity and mortality rank among the top three for a long timeHow to improve the survival rate of patients with advanced gastric cancer is the key to improve the prognosisAt present neoadjuvant chemotherapy combined with immunosuppressants has a higher pathologic complete response pCR rate reduce the clinical stage of tumors and improve the resection rate of radical surgerySome studies have suggested that preserving partial gastric lymph nodes may enhance immunotherapy efficacyProximal radical gastrectomy versus total radical gastrectomy can reduce the scope of surgical resection and preserve some lymph nodes which may contribute to long-term survival and improve postoperative quality of life of patients It is expected to translate the short-term benefit of neoadjuvant immunotherapy into the benefit of patient overall survival OS rateAt the same time our previous studies have shown that the methylation level of PD-L1 K162 can be used as a new indicator to predict the sensitivity of anti-PD -L1 immunotherapy which is expected to be further confirmed in this clinical trialTherefore we plan to conduct a comparative study on the effectiveness and safety of proximal gastric vs total gastric radical resection after SOX combined with anti-PD-1 neoadjuvant therapy for locally advanced upper gastric cancer which is expected to propose new changes in surgical methods for gastric cancer and a new indicator for screening the advantages of gastric cancer immunotherapy in the era of immunotherapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None