Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04863079
Status:
UNKNOWN
Last Update Posted:
2021-04-28
First Post:
2021-04-26
Brief Title:
Pembrolizumab in Post Radical Operation ESCC Patients With Lymph Node Positive KEYSTONE-004
Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Organization:
Tianjin Medical University Cancer Institute and Hospital
Study Overview
Official Title:
Pembrolizumab for Adjuvant Treatment After R0 Resection of Thoracic ESCC Patients With Lymph Node Positive A Single-arm Open-label Phaseâ…¡Trial
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
RECRUITING
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:
The purpose of this study is to observe and evaluate the efficacy and safety of postoperative adjuvant treatment of pembrolizumab in patients with thoracic esophageal squamous cell carcinoma ESCC who have not received neoadjuvant therapy before undergoing R0 resection and have positive postoperative lymph nodes
Detailed Description:
For patients with thoracic esophageal squamous cell carcinoma ESCC who have undergone R0 resection have not received neoadjuvant therapy and have positive postoperative lymph nodes there is no international consensus on whether postoperative adjuvant therapy is required The JCOG9204 study reported that for patients with ESCC with positive lymph nodes after R0 resection postoperative adjuvant chemotherapy can improve the disease-free survival DFS of the ESCC patients However due to the adverse effects of chemotherapy patients are often difficult to tolerate We designed a single-arm open-label phase II trial of pembrolizumab for adjuvant treatment after R0 resection of thoracic ESCC Patients with lymph node positive The purpose of this study is to observe and evaluate the efficacy and safety
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None