Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06272214
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-02-04
Brief Title:
Adjuvant Radiotherapy for Esophageal Squamous Cell Carcinoma in the Era of Immunotherapy
Sponsor:
Zhejiang Cancer Hospital
Organization:
Zhejiang Cancer Hospital
Study Overview
Official Title:
The Role of Adjuvant Radiotherapy in the Treatment for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma After Neoadjuvant Chemotherapy Combined With Immunotherapy A Multi-center Phase II Randomized Clinical Study
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 study is a multicenter prospective randomized phase II trial aimed at exploring the value of adjuvant radiotherapy in patients at high risk of recurrence after neoadjuvant chemoradiotherapy for esophageal cancer The study primarily includes patients with esophageal cancer who underwent neoadjuvant chemoradiotherapy and surgery and did not achieve complete pathological response non-pCR postoperatively and were defined as preoperative clinical stage at T3-4NM0
Eligible patients will be randomized in a 11 ratio into two groups the observation group and the adjuvant radiotherapy group The control group consists of patients who receive surgery after neoadjuvant chemotherapy combined with immunotherapy for esophageal cancer followed by maintenance therapy with PD1PDL1 inhibitors for up to 1 year or until tumor progression The adjuvant radiotherapy group receives additional adjuvant radiotherapy on top of the control groups treatment The specific treatment process involves receiving 2 cycles of neoadjuvant chemotherapy combined with immunotherapy PD1PDL1 inhibitors before potentially curative esophageal cancer surgery The chemotherapy regimen includes paclitaxel in combination with platinum agents with a preference for albumin-bound paclitaxel 280mgm2 on Day 1 or 100mg on Days 1 8 and 15 in combination with carboplatin AUC5 Following surgery patients start adjuvant radiotherapy 4-6 weeks after the operation with a radiation dose of 45Gy25F5W completed no later than 8 weeks post-surgery Two weeks after completing radiotherapy patients continue with immunotherapy maintenance therapy for up to 1 year or until tumor progression Subsequently follow-up visits are scheduled every 3-4 months for the first 3 years every 6 months for the next 2 years and annually thereafter The primary endpoint is 2-year disease-free survival DFS and secondary endpoints include overall survival OS local recurrence-free survival LRFS distant metastasis-free survival DMFS recurrence patterns and safety assessment Additionally the study will explore biomarkers predicting treatment efficacy and adverse reactions in subjects including PD-L1 expression ctDNA clearance status infiltrating immune cell types and quantities cytokine expression and other tumor biomarkers This exploration aims to guide stratified precision treatment for patients
Eligible patients will be randomized in a 11 ratio into two groups the observation group and the adjuvant radiotherapy group The control group consists of patients who receive surgery after neoadjuvant chemotherapy combined with immunotherapy for esophageal cancer followed by maintenance therapy with PD1PDL1 inhibitors for up to 1 year or until tumor progression The adjuvant radiotherapy group receives additional adjuvant radiotherapy on top of the control groups treatment The specific treatment process involves receiving 2 cycles of neoadjuvant chemotherapy combined with immunotherapy PD1PDL1 inhibitors before potentially curative esophageal cancer surgery The chemotherapy regimen includes paclitaxel in combination with platinum agents with a preference for albumin-bound paclitaxel 280mgm2 on Day 1 or 100mg on Days 1 8 and 15 in combination with carboplatin AUC5 Following surgery patients start adjuvant radiotherapy 4-6 weeks after the operation with a radiation dose of 45Gy25F5W completed no later than 8 weeks post-surgery Two weeks after completing radiotherapy patients continue with immunotherapy maintenance therapy for up to 1 year or until tumor progression Subsequently follow-up visits are scheduled every 3-4 months for the first 3 years every 6 months for the next 2 years and annually thereafter The primary endpoint is 2-year disease-free survival DFS and secondary endpoints include overall survival OS local recurrence-free survival LRFS distant metastasis-free survival DMFS recurrence patterns and safety assessment Additionally the study will explore biomarkers predicting treatment efficacy and adverse reactions in subjects including PD-L1 expression ctDNA clearance status infiltrating immune cell types and quantities cytokine expression and other tumor biomarkers This exploration aims to guide stratified precision treatment for patients
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