Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06564298
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
A Study on the Combination of Sintilimab Ramucirumab and Chemotherapy for First-line Treatment of Gastric Cancer With Liver Metastasis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Sintilimab Combined With Ramucirumab and Chemotherapy as First-line Treatment in Patients With Advanced Gastric Cancer With Liver Metastasis RAMSINT A Phase II Single-center Prospective Clinical Study
Status:
NOT_YET_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:
The goal of this clinical trial is to observe the efficacy and safety of Sintilimab a PD-1 inhibitor combined with Ramucirumab a VEGFR-2 antagonist and chemotherapy as a first-line treatment for patients with advanced gastric cancer with liver metastasis
Can the combination of Sintilimab Ramucirumab and chemotherapy improve the prognosis of patients with AGC and liver metastases
What are the adverse events AEs associated with the use of the combination regimen of Sintilimab Ramucirumab and chemotherapy in patients with AGC and liver metastases
Participants will
Receive a combined treatment regimen of Sintilimab Ramucirumab and chemotherapy SOX oxaliplatin and S-1 or XELOX oxaliplatin and capecitabine administered every 21 days for up to 6 cycles Following the completion of 6 cycles maintenance therapy with Sintilimab and oral chemotherapy agents capecitabine or S-1 with or without Ramucirumab will be administered until disease progression
Imaging assessments will be performed at baseline after every 2 cycles of treatment and every 3 months following the completion of 6 cycles of treatment
Can the combination of Sintilimab Ramucirumab and chemotherapy improve the prognosis of patients with AGC and liver metastases
What are the adverse events AEs associated with the use of the combination regimen of Sintilimab Ramucirumab and chemotherapy in patients with AGC and liver metastases
Participants will
Receive a combined treatment regimen of Sintilimab Ramucirumab and chemotherapy SOX oxaliplatin and S-1 or XELOX oxaliplatin and capecitabine administered every 21 days for up to 6 cycles Following the completion of 6 cycles maintenance therapy with Sintilimab and oral chemotherapy agents capecitabine or S-1 with or without Ramucirumab will be administered until disease progression
Imaging assessments will be performed at baseline after every 2 cycles of treatment and every 3 months following the completion of 6 cycles of treatment
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