Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06277024
Status:
RECRUITING
Last Update Posted:
2024-02-26
First Post:
2024-02-04
Brief Title:
A Study on the Safety and Efficacy of the Combination of Candenizumab Lenvatinib and SOX Regimen in the Treatment of HER2 Negative Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Patients
Sponsor:
Fujian Medical University
Organization:
Fujian Medical University
Study Overview
Official Title:
A Study on the Safety and Efficacy of the Combination of Candenizumab Lenvatinib and SOX Regimen in the Treatment of HER2 Negative Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Patients
Status:
RECRUITING
Status Verified Date:
2024-02
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:
Evaluate the objective response rate ORR of the combination of candenizumab lenvatinib and SOX regimen for the treatment of HER2 negative advanced gastric or gastroesophageal junction adenocarcinoma patients
Detailed Description:
Local advanced or metastatic HER2 negative gastric or gastroesophageal junction adenocarcinoma confirmed by histopathology or cytology that cannot be resected and has not received systemic treatment including HER2 inhibitors as the primary treatment for advanced or metastatic diseases in the past
Evaluate the objective response rate ORR of the combination of candenizumab lenvatinib and SOX regimen for the treatment of HER2 negative advanced gastric or gastroesophageal junction adenocarcinoma patients Median survival time OS
Progression free survival time PFS
Duration of relief DOR Evaluate the safety of this regimen in the treatment of advanced gastric or gastroesophageal junction adenocarcinoma patients including the incidence of adverse events AE severe adverse reactions SAE dose adjustment rate and dose pause rate Observe the changes in quality of life of patients with advanced gastric or gastroesophageal junction adenocarcinoma after treatment
Evaluate the objective response rate ORR of the combination of candenizumab lenvatinib and SOX regimen for the treatment of HER2 negative advanced gastric or gastroesophageal junction adenocarcinoma patients Median survival time OS
Progression free survival time PFS
Duration of relief DOR Evaluate the safety of this regimen in the treatment of advanced gastric or gastroesophageal junction adenocarcinoma patients including the incidence of adverse events AE severe adverse reactions SAE dose adjustment rate and dose pause rate Observe the changes in quality of life of patients with advanced gastric or gastroesophageal junction adenocarcinoma after treatment
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?:
False
Is an FDA AA801 Violation?:
None