Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06169410
Status:
RECRUITING
Last Update Posted:
2024-01-23
First Post:
2023-11-19
Brief Title:
Ramucirumab Combined With Nab-paclitaxel Lobaplatin and S-1 in Neoadjuvant Transformation Therapy for Advanced Gastric Cancer
Sponsor:
Yang Jianjun PhD
Organization:
Xijing Hospital
Study Overview
Official Title:
Evaluation of the Efficacy and Safety of Ramucirumab Combined With Nab-paclitaxel Lobaplatin and S-1 in Neoadjuvant and Conversion Therapy for Advanced Gastric Cancer RNPLS-01
Status:
RECRUITING
Status Verified Date:
2024-01
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:
Abstract Objective Ramucirumab is a VEGFR2 antagonist The aim of this trial is to evaluate the efficacy and safety of ramucirumab combined with nab-paclitaxel lobaplatin and S-1 in neoadjuvant and conversion therapy for advanced gastric cancer
Methods and analysis This study is a prospective single-center randomized controlled and open label clinical study containing two cohorts with 140 patients of advanced gastric cancer Cohort A n70 Cohort B n70 The main efficacy indicator is pathological complete response pCR of the cancer after neoadjuvant or conversion therapy The secondary efficacy indicators are R0 resection rate after neoadjuvant or conversion therapy the incidence of adverse events AE progression-free survival PFS overall survival OS objective response rate ORR total response rate and total response time disease control rate DCR and duration of overall response DOR
Ethics Ethics approval has been obtained from the Ethics Committee at the First Affiliated Hospital Xijing Hospital of Air force Military Medical University KY20232220-F-1
Methods and analysis This study is a prospective single-center randomized controlled and open label clinical study containing two cohorts with 140 patients of advanced gastric cancer Cohort A n70 Cohort B n70 The main efficacy indicator is pathological complete response pCR of the cancer after neoadjuvant or conversion therapy The secondary efficacy indicators are R0 resection rate after neoadjuvant or conversion therapy the incidence of adverse events AE progression-free survival PFS overall survival OS objective response rate ORR total response rate and total response time disease control rate DCR and duration of overall response DOR
Ethics Ethics approval has been obtained from the Ethics Committee at the First Affiliated Hospital Xijing Hospital of Air force Military Medical University KY20232220-F-1
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