Ignite Creation Date:
2024-05-06 @ 1:39 PM
Last Modification Date:
2024-10-26 @ 1:17 PM
Study NCT ID:
NCT04086888
Status:
UNKNOWN
Last Update Posted:
2019-09-12
First Post:
2019-09-06
Brief Title:
Real World Study of Immune Checkpoint Inhibitors for Advanced Gastric Cancer
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
Real World Study of Immune Checkpoint Inhibitors for Advanced Gastric Cancer
Status:
UNKNOWN
Status Verified Date:
2019-09
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:
Gastric cancer ranks as the fifth most common and the third most common cause of cancer deaths in the world In spite of the progresses made in the diagnosis and treatment of gastric cancer in the past decades the prognosis is still unsatisfied mainly due to recurrence and distant metastasis Surgical treatment is the first choice for the treatment of early gastric cancer but it is prone to recurrence and metastasis after surgery There are relatively few chemotherapy drugs for gastric cancer Studies have shown that about 13 of gastric cancers have HER2 gene amplification and there are no other known driver gene other than HER-2 At present the targeted therapeutic drugs approved for gastric cancer in China are only trastuzumab and apatinib
Immune checkpoint inhibitors including PD-1 inhibitors PD-L1 inhibitors and CTLA-4 inhibitors have achieved significant therapeutic effects in a variety of tumors and are expected to alter the current state of treatment of tumors In gastric cancer the KEYNOTE-012 study demonstated the efficacy of Pembrolizumab in patients with PD-L1 positive advanced gastric cancer The study showed that 53 of patients had tumor retraction and 22 achieved partial imaging remission with a median duration of 40 weeks At the same time Pembrolizumab is also less toxic than standard second-line chemotherapy However Are the Immune checkpoint inhibitors should be used as single-drug or in combination with chemotherapy Are the Immune checkpoint inhibitors should be used in the first-line or in the back-line And which is the best combination therapy For these issues there is no conclusion yet
This observational study included all patients with gastric cancer who used Immune checkpoint inhibitors in clinical practice regardless of treatment lines and combination with different chemotherapy Through follow-up observations the aim of this study is to analyze the efficacy of Immune checkpoint inhibitors for gastric cancer in the real world and to explore the differences in the efficacy of Immune checkpoint inhibitors in different stages of treatment as well as the efficacy of different chemotherapy combinations so as to provide clinical evidence for the use of immunotherapy for advanced gastric cancer
Immune checkpoint inhibitors including PD-1 inhibitors PD-L1 inhibitors and CTLA-4 inhibitors have achieved significant therapeutic effects in a variety of tumors and are expected to alter the current state of treatment of tumors In gastric cancer the KEYNOTE-012 study demonstated the efficacy of Pembrolizumab in patients with PD-L1 positive advanced gastric cancer The study showed that 53 of patients had tumor retraction and 22 achieved partial imaging remission with a median duration of 40 weeks At the same time Pembrolizumab is also less toxic than standard second-line chemotherapy However Are the Immune checkpoint inhibitors should be used as single-drug or in combination with chemotherapy Are the Immune checkpoint inhibitors should be used in the first-line or in the back-line And which is the best combination therapy For these issues there is no conclusion yet
This observational study included all patients with gastric cancer who used Immune checkpoint inhibitors in clinical practice regardless of treatment lines and combination with different chemotherapy Through follow-up observations the aim of this study is to analyze the efficacy of Immune checkpoint inhibitors for gastric cancer in the real world and to explore the differences in the efficacy of Immune checkpoint inhibitors in different stages of treatment as well as the efficacy of different chemotherapy combinations so as to provide clinical evidence for the use of immunotherapy for advanced gastric 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?:
None