Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04745988
Status:
RECRUITING
Last Update Posted:
2022-11-14
First Post:
2021-02-08
Brief Title:
An Open Label Phase 2 Study to Evaluate the Safety and Efficacy of Lenvatinib With Pembrolizumab or Lenvatinib Pembrolizumab and FLOT in the Neoadjuvant Adjuvant Treatment for Patients With Gastric Cancer
Sponsor:
National Cancer Center Hospital East
Organization:
National Cancer Center Hospital East
Study Overview
Official Title:
An Open Label Phase 2 Study to Evaluate the Safety and Efficacy of Lenvatinib With Pembrolizumab or Lenvatinib Pembrolizumab and FLOT in the Neoadjuvant Adjuvant Treatment for Patients With Gastric Cancer
Status:
RECRUITING
Status Verified Date:
2022-11
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:
This study is an open label phase 2 study to evaluate the safety and efficacy of Lenvatinib with Pembrolizumab or Lenvatinib Pembrolizumab and FLOT in the neoadjuvant adjuvant treatment for Patients with Gastric Cancer
Detailed Description:
This study is an open-label single-arm single-center phase 2 clinical trial Eligible patients are with previously untreated gastric and gastroesophageal junction adenocarcinoma as defined by cT2-4 andor cN without evidence of metastatic disease Patients in the exploratory cohort will receive 3 cycles of 20 mg oral Lenvatinib daily plus 200 mg intravenous Pembrolizumab every 3 weeks as the neoadjuvant treatment followed by surgery and then 3 cycles of Lenvatinib plus Pembrolizumab followed by 11 cycles of Pembrolizumab monotherapy as the adjuvant treatment Also Patients in the FLOT cohort will receive 3 cycles of 8 mg oral Lenvatinib daily 200 mg intravenous Pembrolizumab every 3 weeks and FLOT Docetaxel 50 mgm2 Oxaloplatin 85 mgm2 Levofolinate 200 mgm2 5-FU 2600 mgm2 every 2 weeks as the neoadjuvant treatment followed by surgery and then 3 cycles of Lenvatinib Pembrolizumab plus FLOT followed by 11 cycles of Pembrolizumab monotherapy as the adjuvant 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?:
None
Is an FDA AA801 Violation?:
None