Ignite Creation Date:
2024-05-06 @ 7:33 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06054906
Status:
RECRUITING
Last Update Posted:
2023-09-26
First Post:
2023-09-12
Brief Title:
Neoadjuvant of Sintilimab Combined Weekly Metronomic Chemotherapy PLOF for Resectable Locally Advanced Gastric Cancer
Sponsor:
Huashan Hospital
Organization:
Huashan Hospital
Study Overview
Official Title:
Neoadjuvant of Sintilimab Combined Weekly Metronomic Chemotherapy PLOF for Resectable Locally Advanced Gastric Cancer A Phase Il Study
Status:
RECRUITING
Status Verified Date:
2023-09
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:
To evaluate efficacy and safety of Neoadjuvant of Sintilimab Combined Weekly Metronomic Chemotherapy PLOF in resectable locally advanced gastric cancer
Detailed Description:
This is a single-arm clinical study to enroll 50 patients with gastric cancer cTNM diagnosis of cT3-4aN1-3M0 Each enrolled patient will be assigned a case number Both this case number and the patients initials will be entered on each page of the case report form
Enrolled patients receive a neoadjuvant regimen of POLF in combination with sindilizumab preoperatively they receive a POLF regimen paclitaxel 60 mgm2 oxaliplatin 50 mgm2 and 5-fluorouracil 425 mgm2 administered once weekly for a total of 6 doses and in combination with sindilizumab 200 mg intravenously once every 3 weeks for a total of 2 doses Upon completion of the evaluation patients whose tumors were judged to be resectable underwent radical surgery and received six postoperative doses of the POLF regimen and two doses of Sindilizumab as adjuvant therapy
Postoperative imaging evaluations will be performed every three months until disease recurrence Survival follow-up was performed every three months after disease recurrence Patients will receive neoadjuvant therapy for 6 weeks preoperatively and adjuvant therapy for 6 weeks postoperatively unless intolerable toxicity occurs the patient refuses to continue treatment or treatment is delayed beyond 3 weeks Patients will be under study observation during treatment and 30 days after treatment termination and will receive long-term follow-up for 5 years postoperatively Ultimately pCR and MPR will be the primary study endpoints and ORR DCR 2-year PFS rate 3-year OS rate and safety will be the secondary study endpoints to evaluate the efficacy and safety of the neoadjuvant regimen of POLF combined with sindilizumab as well as to explore the immune activation effect and mechanism of the regimen using peripheral blood and tumor tissue samples
Enrolled patients receive a neoadjuvant regimen of POLF in combination with sindilizumab preoperatively they receive a POLF regimen paclitaxel 60 mgm2 oxaliplatin 50 mgm2 and 5-fluorouracil 425 mgm2 administered once weekly for a total of 6 doses and in combination with sindilizumab 200 mg intravenously once every 3 weeks for a total of 2 doses Upon completion of the evaluation patients whose tumors were judged to be resectable underwent radical surgery and received six postoperative doses of the POLF regimen and two doses of Sindilizumab as adjuvant therapy
Postoperative imaging evaluations will be performed every three months until disease recurrence Survival follow-up was performed every three months after disease recurrence Patients will receive neoadjuvant therapy for 6 weeks preoperatively and adjuvant therapy for 6 weeks postoperatively unless intolerable toxicity occurs the patient refuses to continue treatment or treatment is delayed beyond 3 weeks Patients will be under study observation during treatment and 30 days after treatment termination and will receive long-term follow-up for 5 years postoperatively Ultimately pCR and MPR will be the primary study endpoints and ORR DCR 2-year PFS rate 3-year OS rate and safety will be the secondary study endpoints to evaluate the efficacy and safety of the neoadjuvant regimen of POLF combined with sindilizumab as well as to explore the immune activation effect and mechanism of the regimen using peripheral blood and tumor tissue samples
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