Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06187597
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2023-12-16
Brief Title:
Consolidation of Toripalimab After Chemoradiotherapy in Elderly Esophageal Cancer EC-CRT-007
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
Efficacy and Safety of Toripalimab After Concurrent Chemoradiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma a Multicenter Randomized Phase II Trial EC-CRT-007
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
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:
EC-CRT-007
Brief Summary:
Although definitive chemoradiotherapy CRT is the standard treatment option for unresectable locally advanced esophageal cancer elderly patients tolerate intravenous concurrent CRT less well with age and comorbidities Previous trials have demonstrated that CRT with oral S-1 was tolerable and provided significant survival benefits over radiotherapy alone in elderly patients with esophageal squamous cell carcinoma ESCC However as high as 54 of patients with elderly ESCC experienced locoregional or distant recurrence after CRT Therefore a more effective regimen for older patients is needed Immune checkpoint inhibitors targeting PD-1PD-L1 have shown substantial clinical benefits in advanced esophageal cancer Recently the combination of immunotherapy with CRT has emerged as a promising strategy to improve clinical outcomes in locally advanced esophageal cancer The aim of this study was to evaluate the efficacy and safety of toripalimab an anti-PD-1 antibody after concurrent CRT in elderly patients with locally advanced ESCC
Detailed Description:
A total of 140 patients with elderly unresectable locally advanced ESCC will be stratified according to age 70-80 vs 80 and TNM stage III vs IIIIV and randomly assigned 11 to receive toripalimab as consolidation therapy for up to 12 months arm A or not arm B after definitive radiotherapy with concurrent S-1
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