Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06576973
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-25
Brief Title:
Adbelimumab Combined With Chemotherapy and Apatinib in Patients With Resectable Esophageal Squamous Cell Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Single-arm Single-center Exploratory Study of the Safety and Efficacy of Adbelimumab Combined With Chemotherapy and Apatinib in Patients With Resectable Esophageal Squamous Cell Carcinoma
Status:
RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
Esophageal cancer is a prevalent digestive tract tumor with around 400000 new cases and 300000 deaths globally each year In the past few decades surgery radiotherapy chemotherapy and other treatments were continuously improved however the mortality of esophageal squamous cell carcinoma ESCC patients was not significantly decreased For patients with locally advanced esophageal cancer direct surgery is not effective It is difficult to achieve radical resection by surgery merely and even if many patients receive surgery they may eventually have tumor recurrence and poor survival rate
Therefore it is necessary to explore effective perioperative neoadjuvant treatment to reduce the risk of postoperative recurrence and improve the postoperative survival rate of patients According to the reports the expression of PD-L1 in esophageal cancer was about 414 Therefore PD-1 PD-L1 immunocheckpoint inhibitor may become a new method for the treatment of ESCC Preliminary clinical results showed that immunotherapy combined with chemoradiotherapy provided a synergies antitumor effect
The results of the Phase 1b trial evaluating adbelimumab monotherapy as a neoadjuvant treatment for locally advanced resectable ESCC demonstrated that patients receiving two cycles of neoadjuvant sequential surgery exhibited favorable safety profiles with no adverse reactions of grade 3 or higher The trial reported a major pathological response MPR rate of 24 a pathological complete response pCR rate of 8 a 2-year overall survival OS rate of 92 and a 2-year recurrence-free survival RFS rate of 100 The effectiveness of combining adbelizumab with chemotherapy and targeted therapy for locally advanced esophageal cancer is uncertain
This study aims to assess the efficacy and safety of using adbelizumab with chemotherapy and apatinib as neoadjuvant therapy for resectable ESCC
Therefore it is necessary to explore effective perioperative neoadjuvant treatment to reduce the risk of postoperative recurrence and improve the postoperative survival rate of patients According to the reports the expression of PD-L1 in esophageal cancer was about 414 Therefore PD-1 PD-L1 immunocheckpoint inhibitor may become a new method for the treatment of ESCC Preliminary clinical results showed that immunotherapy combined with chemoradiotherapy provided a synergies antitumor effect
The results of the Phase 1b trial evaluating adbelimumab monotherapy as a neoadjuvant treatment for locally advanced resectable ESCC demonstrated that patients receiving two cycles of neoadjuvant sequential surgery exhibited favorable safety profiles with no adverse reactions of grade 3 or higher The trial reported a major pathological response MPR rate of 24 a pathological complete response pCR rate of 8 a 2-year overall survival OS rate of 92 and a 2-year recurrence-free survival RFS rate of 100 The effectiveness of combining adbelizumab with chemotherapy and targeted therapy for locally advanced esophageal cancer is uncertain
This study aims to assess the efficacy and safety of using adbelizumab with chemotherapy and apatinib as neoadjuvant therapy for resectable ESCC
Detailed Description:
None
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