Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04548440
Status:
COMPLETED
Last Update Posted:
2023-02-15
First Post:
2020-09-09
Brief Title:
Efficacy and Safety of Preoperative Sintilimab Plus Nab-paclitaxel and Cisplatin in BR-ESCC Patients
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
A Phase II Clinical Study of the Efficacy and Safety of Preoperative Sintilimab in Combination With Nab-paclitaxel and Cisplatin in Borderline Resectable Esophageal Squamous Carcinoma
Status:
COMPLETED
Status Verified Date:
2023-02
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:
An open-label non-randomized phase II study to assess the safety and efficacy of Preoperative Sintilimab Plus Nab-paclitaxel and Cisplatin in Borderline Resectable Esophageal Squamous Cell Carcinoma patients
Detailed Description:
PRIMARY OBJECTIVES
To determine the R0 resection rate of Borderline Resectable Esophageal Squamous Cell Carcinoma patients who used preoperative Sintilimab Plus Nab-paclitaxel and Cisplatin
SECONDARY OBJECTIVES
To evaluate the Pathological Complete Response pCR rate Progression Free Survival PFS Relapse Rate Tumor Regression Grading TRG post preoperative chemotherapy Overall Survival OS safety and toxicity of chemotherapy regimen and surgery
EXPLORATORY OBJECTIVES
Exploring the benefits of this treatment strategy in Borderline Resectable Esophageal Squamous Cell Carcinoma patients at a molecular level
OUTLINE
Eligible patients receive Sintilimab and cisplatin intravenously on day 1 and albumin-bound paclitaxel intravenously on days 1 and 8 This cycle is repeated every 3 weeks in the absence of disease progression or unacceptable toxicity Radiological and multidisciplinary assessment is performed after every 2-4 cycles
To determine the R0 resection rate of Borderline Resectable Esophageal Squamous Cell Carcinoma patients who used preoperative Sintilimab Plus Nab-paclitaxel and Cisplatin
SECONDARY OBJECTIVES
To evaluate the Pathological Complete Response pCR rate Progression Free Survival PFS Relapse Rate Tumor Regression Grading TRG post preoperative chemotherapy Overall Survival OS safety and toxicity of chemotherapy regimen and surgery
EXPLORATORY OBJECTIVES
Exploring the benefits of this treatment strategy in Borderline Resectable Esophageal Squamous Cell Carcinoma patients at a molecular level
OUTLINE
Eligible patients receive Sintilimab and cisplatin intravenously on day 1 and albumin-bound paclitaxel intravenously on days 1 and 8 This cycle is repeated every 3 weeks in the absence of disease progression or unacceptable toxicity Radiological and multidisciplinary assessment is performed after every 2-4 cycles
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