Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06601309
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
Biomarker Based Neoadjuvant Strategies for Locally Advanced Resectable ESCC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Biomarker Based Neoadjuvant Strategies for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma an Exploratory Phase II Single-arm Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-09
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:
ESCC
Brief Summary:
This study aims to evaluate the impact of the neoadjuvant treatment strategy based on CPS score on the pathological complete response pCR rate in patients with resectable locally advanced esophageal cancer
Detailed Description:
Esophageal cancer is a malignant tumor with a high incidence in China with most patients diagnosed at the advanced stage Traditional treatment modalities include surgery chemoradiotherapy and chemotherapy However under current standard treatments approximately 50 of patients remain incurable primarily due to postoperative recurrence and distant metastasis Therefore seeking a new treatment strategy to improve efficacy is crucial
This clinical trial aims to evaluate the use of immune checkpoint inhibitors in neoadjuvant therapy based on CPS scoring to enhance the pathologic complete response pCR rate Patients pathologically confirmed with esophageal squamous cell carcinoma ESCC will undergo surgical assessment for operability Eligible patients will further undergo CPS testing and will receive different neoadjuvant treatment strategies based on CPS results patients with CPS 20 will receive neoadjuvant immunotherapy alone CPS 10-20 patients will receive neoadjuvant chemotherapy followed by immunotherapy and CPS 10 patients will receive standard neoadjuvant chemoradiotherapy
After completing neoadjuvant therapy patients will rest for 4-6 weeks before undergoing curative surgery which will be reassessed by thoracic surgeons for R0 resection feasibility preoperatively Postoperatively pathological evaluation will assess the pCR rate and other secondary study endpoints with the most severe toxicities included in the analysis
This study anticipates a group-wide pCR rate of 45 based on a PD-L1 biomarker-guided neoadjuvant treatment strategy The trial is designed to exclude a pCR rate of 30 or lower using a one-sided 95 confidence interval α set at 0025 and 80 statistical power with a total sample size of 90 The null hypothesis will be rejected if fewer than 34 patients achieve pCR in the entire cohort
Based on reference studies EC-CRT-001 ESCORT-1 JUPITER-06 and KEYNOTE-590 and CPS distribution data for esophageal squamous cell carcinoma from our institution it is expected that the proportions of patients with CPS 20 10-20 and 10 will be 10 40 and 50 respectively corresponding to 9 36 and 45 eligible patients for each group It is anticipated that biological specimens will be obtained from more than 30 patients
This clinical trial aims to evaluate the use of immune checkpoint inhibitors in neoadjuvant therapy based on CPS scoring to enhance the pathologic complete response pCR rate Patients pathologically confirmed with esophageal squamous cell carcinoma ESCC will undergo surgical assessment for operability Eligible patients will further undergo CPS testing and will receive different neoadjuvant treatment strategies based on CPS results patients with CPS 20 will receive neoadjuvant immunotherapy alone CPS 10-20 patients will receive neoadjuvant chemotherapy followed by immunotherapy and CPS 10 patients will receive standard neoadjuvant chemoradiotherapy
After completing neoadjuvant therapy patients will rest for 4-6 weeks before undergoing curative surgery which will be reassessed by thoracic surgeons for R0 resection feasibility preoperatively Postoperatively pathological evaluation will assess the pCR rate and other secondary study endpoints with the most severe toxicities included in the analysis
This study anticipates a group-wide pCR rate of 45 based on a PD-L1 biomarker-guided neoadjuvant treatment strategy The trial is designed to exclude a pCR rate of 30 or lower using a one-sided 95 confidence interval α set at 0025 and 80 statistical power with a total sample size of 90 The null hypothesis will be rejected if fewer than 34 patients achieve pCR in the entire cohort
Based on reference studies EC-CRT-001 ESCORT-1 JUPITER-06 and KEYNOTE-590 and CPS distribution data for esophageal squamous cell carcinoma from our institution it is expected that the proportions of patients with CPS 20 10-20 and 10 will be 10 40 and 50 respectively corresponding to 9 36 and 45 eligible patients for each group It is anticipated that biological specimens will be obtained from more than 30 patients
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