Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT05593458

PHASE3

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

Sponsor: Zhejiang University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

190

Start Date

2023-04-01

Completion Date

2026-12

Last Updated

2025-04-09

Healthy Volunteers

Conditions

Locally Advanced Gastric Carcinoma

Interventions

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.

Inclusion Criteria: * 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). Exclusion Criteria: * Patients can not bear surgical procedure. * Pregnant or lactating women. * HER2 overexpression(+++) confirmed by immunohistochemistry. * Previous cytotoxic chemotherapy, radiotherapy or immunotherapy. * History of another malignancy within the last five years. * History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the Investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake. * Clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication or myocardial infarction within the last 12 months. * History of dysphagia, complete or partial gastrointestinal obstruction, active gastrointestinal bleeding and gastrointestinal perforation; * Organ allografts requiring immunosuppressive therapy. * Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease. * Moderate or severe renal impairment: serum creatinine \> 1.5 x upper limit of normal (ULN). * Hypersensitivity to any drug of the study regimen. * With abdominal cavity implantation metastasis or distant metastasis. * Unwilling or unable to comply with the protocol for the duration of the study.

Locations (1)

Gastrointestinal Department of Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (1)