Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06509568
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Neoadjuvant ChemoRadiotherapy Followed by Immunotherapy and Surgery for Resectable Esophageal Squamous Cell CarcinomaCRIS-2 Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of Neoadjuvant Chemoradiotherapy Followed by Immunotherapy With Neoadjuvant Chemoimmunotherapy in the Treatment for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma A Multi-center Phase II Randomized Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Based on our previous single-arm Phase Ib study CRIS trial NCT06303583 we observed that neoadjuvant chemoradiotherapy followed by immunotherapy nCRIT significantly increased the pathological complete response pCR rate achieving approximately 60 in locally advanced esophageal squamous cell carcinomaESCC We plan to initiate a multicenter prospective randomized phase II trial designed to compare the efficacy and safety of neoadjuvant chemoimmunotherapy nCIT versus neoadjuvant chemoradiotherapy followed by immunotherapy nCRIT in treating esophageal squamous cell carcinoma The primary study population includes patients with operable or potentially operable thoracic ESCC classified as cT3-4aN0 or T2-4aN based on endoscopy enhanced chest and abdominal CT and whole-body PET scans Eligible participants are aged 18-75 years with an ECOG performance status of 0-1 Qualified patients will be randomly assigned in a 11 ratio to either the nCRIT group or the nCIT group
Patients in the nCRIT group will receive neoadjuvant concurrent chemoradiotherapy radiation therapy will be administered using IMRT or VMAT with involved-field irradiation at a dose of PTV 414 Gy23 fractions31 days Chemotherapy will consist of weekly administration of paclitaxel albumin-bound 50 mgm² and carboplatin AUC2 for five weeks given on the days of radiotherapy Patients who do not progress on CT and meet immunotherapy criteria will receive fixed-dose toripalimab 200 mg IV on days 8 and 29 after chemoradiotherapy followed by minimally invasive esophagectomy four weeks after completing immunotherapy
Patients in the nCIT group will receive two cycles of TC chemotherapy combined with immunotherapy specifically paclitaxel albumin-bound 100 mgm² on days 1 8 15 or 260mgm² d1 carboplatin AUC5 on days 1 and toripalimab 200 mg on days 1 Minimally invasive esophagectomy will be performed 4-6 weeks after completing chemotherapy and adjuvant immunotherapy is recommended for one year after surgery
The primary endpoint of the study is the pathological complete response pCR Secondary endpoints include treatment safety CT imaging response rate R0 resection rate major pathological response MPR 2-year event-free survival EFS 2-year overall survival OS in the intention-to-treat ITT population and analysis of treatment failure reasons
Patients in the nCRIT group will receive neoadjuvant concurrent chemoradiotherapy radiation therapy will be administered using IMRT or VMAT with involved-field irradiation at a dose of PTV 414 Gy23 fractions31 days Chemotherapy will consist of weekly administration of paclitaxel albumin-bound 50 mgm² and carboplatin AUC2 for five weeks given on the days of radiotherapy Patients who do not progress on CT and meet immunotherapy criteria will receive fixed-dose toripalimab 200 mg IV on days 8 and 29 after chemoradiotherapy followed by minimally invasive esophagectomy four weeks after completing immunotherapy
Patients in the nCIT group will receive two cycles of TC chemotherapy combined with immunotherapy specifically paclitaxel albumin-bound 100 mgm² on days 1 8 15 or 260mgm² d1 carboplatin AUC5 on days 1 and toripalimab 200 mg on days 1 Minimally invasive esophagectomy will be performed 4-6 weeks after completing chemotherapy and adjuvant immunotherapy is recommended for one year after surgery
The primary endpoint of the study is the pathological complete response pCR Secondary endpoints include treatment safety CT imaging response rate R0 resection rate major pathological response MPR 2-year event-free survival EFS 2-year overall survival OS in the intention-to-treat ITT population and analysis of treatment failure reasons
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None