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
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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, American Joint Committee on Cancer (AJCC) TNM staging system 8th edition)

• Life expectancy more than 3 months

• Give written informed consent, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.

• Normal hepatic, renal, and bone marrow function (ALT/AST\<2.5 fold of upper limit value;Tbil\<1.5mg/dl, Cr\<1.5 fold of upper limit value; White Blood Cell count≥3 × 10\^9/L, ANC ≥ 1.5 × 10\^9/L,PLT≥ 80 × 10\^9/L,Hb ≥ 90 g/L).

Locations
Other Locations
China
Gastrointestinal Department of Second Affiliated Hospital of Zhejiang University
RECRUITING
Hangzhou
Contact Information
Primary
Shenbin XU, Doctor
shenbin_xu@zju.edu.cn
86-15057315353
Time Frame
Start Date: 2023-04-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 190
Treatments
Experimental: Arterial infusion group
1. 3 cycles of neoadjuvant chemotherapy: Oxaliplatin arterial infusion+S-1~2. 3 cycles of immunotherapy: sintilimab~3. surgery and 3 cycles of adjuvant chemotherapy using SOX regimen plus sintilimab.~4. S-1 administration till 1 year after surgery
Active_comparator: SOX group
1. 3 cycles of neoadjuvant chemotherapy: SOX regimen~2. 3 cycles of immunotherapy: sintilimab~3. surgery and 3 cycles of adjuvant chemotherapy using SOX regimen plus sintilimab.~4. S-1 administration till 1 year after surgery
Related Therapeutic Areas
Sponsors
Leads: Zhejiang University

This content was sourced from clinicaltrials.gov

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