Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2026-01-05 @ 6:29 PM
Study NCT ID:
NCT04890392
Status:
UNKNOWN
Last Update Posted:
2021-08-12
First Post:
2021-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tislelizumab Combined With S-1 Plus Oxaliplatin as a Neoadjuvant Treatment in Patients With GC/GEJC
Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Organization:
Study Overview
Official Title:
A Single-arm Exploratory Study of Safety and Efficacy of Tislelizumab in Combination With S-1 Plus Oxaliplatin as a Neoadjuvant Treatment in Patients With Advanced Gastric/Gastroesophageal Junction Cancer
Status:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
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:
At present, the treatment of advanced gastric/gastroesophageal junction cancer is a research hotspot in the academic community. In Asia, Siewert type II and type III are the main types of advanced gastric/gastroesophageal junction cancer. The current consensus in the academic community for the treatment of this part of the tumor is based on the principles of diagnosis and treatment of gastric cancer, of which the value of neoadjuvant therapy in this part of the tumor has been paid more and more attention by scholars. However, there is no highly recognized neoadjuvant therapy. The current situation will promote the development of advanced gastric/gastroesophageal junction cancer to accurate preoperative staging, more accurate population screening, more accurate targets and molecular markers. Immunotherapy is a promising application in oncology. Several PD1/PD-L1 monoclonal antibodies are approved by FDA for the clinical treatment of melanoma and other tumors. Previous clinical studies have shown that PD1/PD-L1 has limited efficacy in digestive tract tumors. However, on ASCO in 2020, Asian analysis of KEYNOTE-062 study showed that in HER-2 negative advanced gastric cancer with PD-1 combined positive score (CPS) ≥ 1 and CPS ≥ 10, the OS of PD-1 inhibitor treatment was superior to that of chemotherapy group, with 24-month OS rate (CPS ≥ 1, 45% VS 23%, CPS ≥ 10, 54% VS 27%). Meanwhile, the results of PACIFIC study phase III clinical trial showed that the 3-year OS of PD-L1 monoclonal antibody combined with radiotherapy in advanced unresectable lung cancer was as high as 57%, which is expected to completely rewrite its clinical practice. Immunotherapy is promising in cancer therapy. This study intends to use immunotherapy combined with SOX (S-1 + Oxaliplatin) as a neoadjuvant therapy for advanced gastric/gastroesophageal junction cancer.
Detailed Description:
None
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?: