Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-25 @ 4:43 PM
Study NCT ID:
NCT04654403
Status:
UNKNOWN
Last Update Posted:
2021-08-23
First Post:
2020-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of First-line Camrelizumab With or Without Chemotherapy for Advanced Esophageal Squamous Cell Cancer
Sponsor:
The First Affiliated Hospital of Zhengzhou University
Organization:
Study Overview
Official Title:
Phase II Study of First-line Camrelizumab With or Without Chemotherapy for Advanced Esophageal Squamous Cell Cancer
Status:
UNKNOWN
Status Verified Date:
2021-08
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:
The purpose of this study is to evaluate the efficacy and safety of Camrelizumab or Camrelizumab plus chemotherapy in patients with untreated, advanced ESCC with PD-L1 CPS≥10 ,who have been achieved PR and CR after treated with Camrelizumab.
Detailed Description:
Standard 1L chemotherapy for advanced or metastatic esophageal squamous cell cancer(ESCC) results in poor OS(median\<1year).Camrelizumab provided superior OS versus chemotherapy in heavily pretreated advanced/rucurrent ESCC.PD-1 antibody +chemo showed promisng antitumor activity in 1L advanced or metastatic ESCC.PD-L1 expression by CPS at cutoff≥10 has shown better enrichment for efficacy fo checkpoint inhibitors in ESCC.Recently, two clinical trials on Pembrolizumb have attracted our attention,KEYNOTE-181 and KEYNOTE-590.The median duration of response was 9.3 months in pembrolizumab monotherapy (KEYNOTE-181) ,and 8.3 months in Pembrolizumb plus chemotherapy (KEYNOTE-590). We hypothesis that administration of the PD-1 inhibitor will significantly prolong survival compared to PD-1 inhibitor combined with chemotherapy, when used as maintenance therapy in patients sensitive to PD-1 inhibitors.
Study Oversight
Has Oversight DMC:
False
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?: