Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06413342
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-05-08
Brief Title:
Sintilimab After Concurrent Chemoradiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma
Sponsor:
Zhejiang Cancer Hospital
Organization:
Zhejiang Cancer Hospital
Study Overview
Official Title:
Sintilimab After Concurrent Chemoradiotherapy in Elderly Patients With Unresectable Esophageal Squamous Cell Carcinoma A Randomized Multi-center Phase II Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-07
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:
This trial is a prospective randomized controlled multicenter phase II clinical study to evaluate the efficacy and safety of sintilimab as consolidation therapy in elderly patients with esophageal cancer who did not progress after concurrent chemoradiotherapy
Patients aged 70-85 years with esophageal squamous cell carcinoma who did not progress after concurrent chemoradiotherapy and meet the inclusion criteria will be stratified according to MRD status positive vs negative and randomized in a 11 ratio into two groups the treatment group receiving sintilimab for patients with a weight 60 kg 3 mgkg IV on Day 1 every 3 weeks for patients with a weight 60 kg 200 mg IV on Day 1 every 3 weeks and the observation group receiving regular follow-up Patients should receive the first dose within 42 days after completing the last radiotherapy session and continue treatment until disease progression intolerable toxicity loss to follow-up death or other circumstances where the investigator determines treatment should be discontinued whichever occurs first The maximum duration of sintilimab treatment is 12 months from the start of treatment while the observation group will be followed up every 3 months for at least one year No other anti-tumor treatments are allowed during the study period The study aims to compare the effects of the two treatment modalities on progression-free survival overall survival tumor response toxicity reactions and quality of life in elderly patients with esophageal cancer
Patients aged 70-85 years with esophageal squamous cell carcinoma who did not progress after concurrent chemoradiotherapy and meet the inclusion criteria will be stratified according to MRD status positive vs negative and randomized in a 11 ratio into two groups the treatment group receiving sintilimab for patients with a weight 60 kg 3 mgkg IV on Day 1 every 3 weeks for patients with a weight 60 kg 200 mg IV on Day 1 every 3 weeks and the observation group receiving regular follow-up Patients should receive the first dose within 42 days after completing the last radiotherapy session and continue treatment until disease progression intolerable toxicity loss to follow-up death or other circumstances where the investigator determines treatment should be discontinued whichever occurs first The maximum duration of sintilimab treatment is 12 months from the start of treatment while the observation group will be followed up every 3 months for at least one year No other anti-tumor treatments are allowed during the study period The study aims to compare the effects of the two treatment modalities on progression-free survival overall survival tumor response toxicity reactions and quality of life in elderly patients with esophageal 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