Ignite Creation Date:
2024-05-06 @ 6:15 PM
Last Modification Date:
2024-10-26 @ 2:44 PM
Study NCT ID:
NCT05593458
Status:
RECRUITING
Last Update Posted:
2023-12-15
First Post:
2022-10-19
Brief Title:
Transarterial Neoadjuvant Chemotherapy vsTraditional Intravenous Chemotherapy For Locally Advanced Gastric Cancer With SOXPD-1
Sponsor:
Zhejiang University
Organization:
Zhejiang University
Study Overview
Official Title:
A Multicenter Randomized Controlled Study of S-1 Combined With Oxaliplatin by Arterial Infusion Plus PD-1 Antibody Versus Conventional SOX Chemotherapy Plus PD-1 Antibody for Locally Advanced Gastric Cancer
Status:
RECRUITING
Status Verified Date:
2023-12
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:
TACTIC
Brief Summary:
SOX regimen consisting of oral S-1 and intravenous oxaliplatin is the preferred regimen for perioperative chemotherapy for gastric cancer The goal of this clinical trial is to compare the efficacy and safety between S-1 combined with oxaliplatin by arterial infusion as neoadjuvant chemotherapy and conventional SOX regimen in locally advanced gastric cancer The main question it aims to answer is whether arterially infused oxaliplatin plus S-1 has the potential to be a better neoadjuvant option for patients with locally advanced gastric cancer
Participants will be randomised and receive
3 cycles of conventional SOX chemotherapy plus PD-1 antibody or arterial infused oxaliplatin plus S-1 and PD-1 antibody as neoadjuvant chemotherapy
Adequate gastric resection along with D2 lymph node dissection
3 cycles adjuvant chemotherapy using SOX regimen plus PD-1 antibody
Administration of S-1 regularly till 1 year after surgery
Researchers will compare Major pathological response rate MPR pathologic complete response ratepCRthe 2-year overall survival OS rates 2-year disease free survival DFS R0 resection rates and adverse events to see if the modified perioperative chemotherapy improve the prognosis of patients with locally advanced gastric cancer
Participants will be randomised and receive
3 cycles of conventional SOX chemotherapy plus PD-1 antibody or arterial infused oxaliplatin plus S-1 and PD-1 antibody as neoadjuvant chemotherapy
Adequate gastric resection along with D2 lymph node dissection
3 cycles adjuvant chemotherapy using SOX regimen plus PD-1 antibody
Administration of S-1 regularly till 1 year after surgery
Researchers will compare Major pathological response rate MPR pathologic complete response ratepCRthe 2-year overall survival OS rates 2-year disease free survival DFS R0 resection rates and adverse events to see if the modified perioperative chemotherapy improve the prognosis of patients with locally advanced gastric cancer
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