Actively Recruiting
Transarterial Neoadjuvant Chemotherapy vs.Traditional Intravenous Chemotherapy For Locally Advanced Gastric Cancer With SOX+PD-1
Led by Zhejiang University · Updated on 2025-04-09
190
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Transarterial Neoadjuvant Chemotherapy vs.Traditional Intravenous Chemotherapy For Locally Advanced Gastric Cancer With SOX+PD-1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eastern Cooperative Oncology Group (ECOG) score 0-1
- Ambulatory males or females aged 18-75 years
- Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (Siewert type II or III)
- Locally advanced gastric carcinoma (cT3N2-3M0, cT4aN1-3M0, cT4bNanyM0, AJCC TNM staging 8th edition)
- Life expectancy more than 3 months
- Written informed consent given
- Normal liver, kidney, and bone marrow function (ALT/AST <2.5 times upper limit; Tbil <1.5 mg/dl; Cr <1.5 times upper limit; WBC ≥3 × 10^9/L; ANC ≥1.5 × 10^9/L; PLT ≥80 × 10^9/L; Hb ≥90 g/L)
You will not qualify if you...
- Unable to undergo surgery
- Pregnant or breastfeeding women
- HER2 overexpression (+++) confirmed by immunohistochemistry
- Previous chemotherapy, radiotherapy, or immunotherapy
- History of another cancer within the last 5 years
- Uncontrolled seizures, central nervous system disorders, or psychiatric disability affecting consent or compliance
- Active significant heart disease or recent serious cardiac events
- History of dysphagia, gastrointestinal obstruction, bleeding, or perforation
- Organ transplant requiring immunosuppression
- Serious uncontrolled infections or other serious diseases
- Moderate or severe kidney impairment (serum creatinine > 1.5 times upper limit)
- Allergic reaction to study drugs
- Presence of abdominal cavity implantation metastasis or distant metastasis
- Unwilling or unable to follow the study protocol
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Trial Site Locations
Total: 1 location
1
Gastrointestinal Department of Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
S
Shenbin XU, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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