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

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

NCT ID: NCT05593458

Condition: Locally Advanced Gastric Carcinoma

Conditions: Official terms:
Stomach Neoplasms
Oxaliplatin

Conditions: Keywords:
gastric cancer
arterial infusion
neoadjuvant therapy
immunotherapy

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Oxaliplatin by arterial infusion plus S-1
Description: 3 cycles oxaliplatin by arterial infusion plus S-1 every 21 days as neoadjuvant chemotherapy.
Arm group label: Arterial infusion group

Intervention type: Drug
Intervention name: SOX neoadjuvant
Description: 3 cycles of SOX neoadjuvant chemotherapy every 21 days.
Arm group label: SOX group

Intervention type: Drug
Intervention name: Sintilimab neoadjuvant
Description: 3 cycles of neoadjuvant immunotherapy every 21 days.
Arm group label: Arterial infusion group
Arm group label: SOX group

Intervention type: Procedure
Intervention name: gastrectomy plus D2 lymph node dissection
Description: All patients, whose lesions are resectable and medically operable after 3 cycles neoadjuvant chemotherapy, will receive gastrectomy plus D2 lymph node dissection.
Arm group label: Arterial infusion group
Arm group label: SOX group

Intervention type: Drug
Intervention name: SOX adjuvant, Sequential S-1
Description: 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.
Arm group label: Arterial infusion group
Arm group label: SOX group

Intervention type: Drug
Intervention name: Sintilimab adjuvant
Description: 3 cycles of adjuvant immunotherapy every 21 days.
Arm group label: Arterial infusion group
Arm group label: SOX group

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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Gastrointestinal Department of Second Affiliated Hospital of Zhejiang University

Address:
City: Hangzhou
Zip: 310000
Country: China

Status: Recruiting

Contact:
Last name: Shenbin XU, Doctor

Phone: 86-15057315353
Email: shenbin_xu@zju.edu.cn

Start date: April 1, 2023

Completion date: December 2026

Lead sponsor:
Agency: Zhejiang University
Agency class: Other

Source: Zhejiang University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05593458