Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06339060
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-03-16
Brief Title:
An Organ Preservation Strategies After Chemoradiotherapy Combined With Immunotherapy for Esophageal Cancer PALACE3
Sponsor:
Ruijin Hospital
Organization:
Ruijin Hospital
Study Overview
Official Title:
An Organ Preservation Strategies After Chemoradiotherapy Combined With Immunotherapy for Esophageal Cancer vs Cross Therapy
Status:
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:
PALACE3
Brief Summary:
Patients with locally advanced esophageal squamous cell carcinoma will randomly assigned to receive neoadjuvant chemo-radiotherapy combined with immunotherapy post organ preservation strategy experimental group or neoadjuvant chemo-radiotherapy followed by surgery control group
The 3-year overall survival rate is the primary outcome
The 3-year overall survival rate is the primary outcome
Detailed Description:
The investigators will conduct the open multicenter prospective randomized controlled clinical studyPALACE3 Patients with locally advanced esophageal squamous cell carcinoma will randomly assigned to either receive neoadjuvant synchronous radiotherapy and chemotherapy combined with immunotherapy followed by organ preservation strategy experimental group Arm1 or neoadjuvant concurrent radiotherapy and chemotherapy followed by radical surgery control groupArm 2 Collect relevant data on preoperative treatment re examination after neoadjuvant therapy perioperative and long-term follow-up of patients and evaluate the clinical treatment effects cCR rate surgical pathological results pCR rate R0 resection rate tumor regression grade lymph node positivity rate neoadjuvant therapy and perioperative complications long-term oncological effects total survival disease-free survival and quality of life of the two treatment plans through statistical analysis
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