Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06342167
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-03-26
Brief Title:
Efficacy and Safety of Concurrent PD-1 Inhibitor and Radiotherapy With Immunonutrition for Esophageal Squamous Cell Carcinoma
Sponsor:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Organization:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Study Overview
Official Title:
Efficacy and Safety of Concurrent Sintilimab and Radiotherapy With Immunonutrition Support in Esophageal Cancer A Phase II Multicenter Clinical Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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:
None
Brief Summary:
At present concurrent chemoradiotherapy cCRT with platin-based dual-drug regimen is the standard treatment for inoperable locally advanced esophageal cancer in patients with a good performance status However cCRT has substantial toxic effects and a large number of patients with older age malnutrition and other morbidities cannot tolerate cCRT Several phase II trials showed combining PD-1 inhibitor with definitive cCRT provided encouraging activity and acceptable toxicity in patients with locally advanced esophageal squamous cell carcinoma LA-ESCC
Therefore this single-arm multicenter phase II trial aims to assess the efficacy and safety of immunotherapy plus radiotherapy with immunonutrition support in patients with LA-ESCC and positive PD-L1 expression who are intolerant to cCRT
Therefore this single-arm multicenter phase II trial aims to assess the efficacy and safety of immunotherapy plus radiotherapy with immunonutrition support in patients with LA-ESCC and positive PD-L1 expression who are intolerant to cCRT
Detailed Description:
This single-arm trial is designed to evaluate the efficacy and safety of concurrent immunotherapy sintilimab plus radiotherapy with immunonutrition support enteral nutritional emulsion TPF-T followed by consolidation immunotherapy in inoperable patients with locally advanced or early stage esophageal squamous cell carcinoma who are PD-L1 positive expression and intolerant to cCRT The eligible patients will receive concurrent treatment consisting of total dose of 50-60 Gy in 25-30 fractions and 200 mg of sintilimab administered every three weeks along with enteral nutritional emulsion TPF-T support 600-1600 ml per day according to the nutrition status evaluation The primary outcome is 1-year progression-free survival PFS rate The investigators hypothesized PD-L1 inhibitor plus radiotherapy will improve the 1-year PFS from 40 to 60 Then 58 patients will be needed in total The secondary outcomes will include objective response rate ORR overall survival OS progression-free and overall survival and incidence of adverse events
This study is approval by the National GCP Center for Anticancer Drugs Independent Ethics Committee National Cancer CenterCancer Hospital Chinese Academy of Medical Science and Peking Union Medical College Study ID 24074-4354
This study is approval by the National GCP Center for Anticancer Drugs Independent Ethics Committee National Cancer CenterCancer Hospital Chinese Academy of Medical Science and Peking Union Medical College Study ID 24074-4354
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