NCT05593458

Transarterial Neoadjuvant Chemotherapy vs.Traditional Intravenous Chemotherapy For Locally Advanced Gastric Cancer With SOX+PD-1

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 190 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 rate（pCR）,the 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.

Conditions

• Locally Advanced Gastric Carcinoma

Interventions

Type	Name	Description
DRUG	Oxaliplatin by arterial infusion plus S-1	3 cycles oxaliplatin by arterial infusion plus S-1 every 21 days as neoadjuvant chemotherapy.
DRUG	SOX neoadjuvant	3 cycles of SOX neoadjuvant chemotherapy every 21 days.
DRUG	Sintilimab neoadjuvant	3 cycles of neoadjuvant immunotherapy every 21 days.
PROCEDURE	gastrectomy plus D2 lymph node dissection	All patients, whose lesions are resectable and medically operable after 3 cycles neoadjuvant chemotherapy, will receive gastrectomy plus D2 lymph node dissection.
DRUG	SOX adjuvant, Sequential S-1	3 cycles of SOX adjuvant chemotherapy every 21 days after surgery in both groups. Sequential S-1 chemotherapy every 21 days till 1 year postoperation.
DRUG	Sintilimab adjuvant	3 cycles of adjuvant immunotherapy every 21 days.

Timeline

• Start date: 2023-04-01
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2022-10-25
• Last updated: 2025-04-09

Locations

1 site across 1 country: China