Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06430658
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-05-13
Brief Title:
Neoadjuvant Comprehensive Treatment for Unresectable Esophageal Cancer
Sponsor:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Organization:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Study Overview
Official Title:
NEoadjuvant Total rX for Borderline Unresectable Esophageal Squamous Cell Carcinoma a Prospective Randomized Three-Arm Open-Label Phase II Trial NEXUS-2
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:
NEXUS-2
Brief Summary:
Patients diagnosed with locally advanced esophageal squamous cell carcinoma ESCC that is deemed unresectable face a bleak prognosis Recent phase 12 studies have demonstrated the efficacy and safety of augmenting neoadjuvant concurrent chemoradiotherapy with immunotherapy in treating resectable ESCC The present study is a prospective 3-arm randomized trial that seeks to evaluate the efficacy of diverse conversion therapy modalities in patients with unresectable ESCC The study objectives include R0 resection rate treatment-related adverse events morbidity and mortality 1-year progression-free survival PFS and 1-year overall survival OS rates
Tislelizumab is a humanized IgG4 monoclonal antibody with high affinityspecificity for programmed cell death protein 1 PD-1 Tislelizumab was specifically engineered to minimize binding to FcɤR on macrophages thereby abrogating antibody-dependent phagocytosis a potential mechanism of T-cell clearance and resistance to anti-PD-1 therapy
This trial will provide valuable insights into the effectiveness of the three conversion therapy modalities and help to inform clinical decision-making for patients with unresectable locally advanced ESCC
Tislelizumab is a humanized IgG4 monoclonal antibody with high affinityspecificity for programmed cell death protein 1 PD-1 Tislelizumab was specifically engineered to minimize binding to FcɤR on macrophages thereby abrogating antibody-dependent phagocytosis a potential mechanism of T-cell clearance and resistance to anti-PD-1 therapy
This trial will provide valuable insights into the effectiveness of the three conversion therapy modalities and help to inform clinical decision-making for patients with unresectable locally advanced ESCC
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