Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06388135
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-04-18
Brief Title:
Serplulimab Combined With Nab-paclitaxel and Cisplatin in Neoadjuvant Therapy for Resectable Esophageal Squamous Cell Carcinoma
Sponsor:
Yang Jianjun PhD
Organization:
Xijing Hospital
Study Overview
Official Title:
Serplulimab Combined With Nab-paclitaxel and Cisplatin in Neoadjuvant Therapy for Resectable Esophageal Squamous Cell Carcinoma a Study Protocol of Prospective Single-center Open Label and Exploratory Cohort Study SNC-01
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
Abstract Objective This study aims to investigate the potential clinical impact of neoadjuvant immunotherapy in resectable esophageal squamous cell carcinoma ESCC
The efficacy and safety of combining the programmed death 1 PD-1 inhibitor serplulimab with nab-paclitaxel and cisplatin as neoadjuvant therapy in patients with resectable ESCC will be evaluated Methods and analysis A prospective single-center open-label cohort study will enroll 80 patients with 40 patients allocated to the experimental group and 40 patients to the control group Patients in the experimental arm will undergo 3 cycles of neoadjuvant therapy comprising serplulimab cisplatin and nab-paclitaxel while those in the control arm will receive 3 cycles of neoadjuvant therapy with cisplatin and nab-paclitaxel The primary efficacy endpoint will be the assessment of pathological complete response pCR following neoadjuvant therapy Secondary efficacy endpoints will include major pathological response MPR disease-free survival objective response rate ORR and monitoring of adverse events AEs
Ethics Ethics approval has been obtained from the Ethics Committee at the First Affiliated Hospital Xijing Hospital of Air force Military Medical University KY20242052-C-1
The efficacy and safety of combining the programmed death 1 PD-1 inhibitor serplulimab with nab-paclitaxel and cisplatin as neoadjuvant therapy in patients with resectable ESCC will be evaluated Methods and analysis A prospective single-center open-label cohort study will enroll 80 patients with 40 patients allocated to the experimental group and 40 patients to the control group Patients in the experimental arm will undergo 3 cycles of neoadjuvant therapy comprising serplulimab cisplatin and nab-paclitaxel while those in the control arm will receive 3 cycles of neoadjuvant therapy with cisplatin and nab-paclitaxel The primary efficacy endpoint will be the assessment of pathological complete response pCR following neoadjuvant therapy Secondary efficacy endpoints will include major pathological response MPR disease-free survival objective response rate ORR and monitoring of adverse events AEs
Ethics Ethics approval has been obtained from the Ethics Committee at the First Affiliated Hospital Xijing Hospital of Air force Military Medical University KY20242052-C-1
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