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

NCT ID: NCT05593458

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2026-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Oxaliplatin by arterial infusion plus S-1

Intervention Type: DRUG

3 cycles oxaliplatin by arterial infusion plus S-1 every 21 days as neoadjuvant chemotherapy.

Sintilimab neoadjuvant

Intervention Type: DRUG

3 cycles of neoadjuvant immunotherapy every 21 days.

gastrectomy plus D2 lymph node dissection

Intervention Type: PROCEDURE

All patients, whose lesions are resectable and medically operable after 3 cycles neoadjuvant chemotherapy, will receive gastrectomy plus D2 lymph node dissection.

SOX adjuvant, Sequential S-1

Intervention Type: DRUG

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.

Sintilimab adjuvant

Intervention Type: DRUG

3 cycles of adjuvant immunotherapy every 21 days.

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

Group Type: ACTIVE_COMPARATOR

SOX neoadjuvant

Intervention Type: DRUG

3 cycles of SOX neoadjuvant chemotherapy every 21 days.

Sintilimab neoadjuvant

Intervention Type: DRUG

3 cycles of neoadjuvant immunotherapy every 21 days.

gastrectomy plus D2 lymph node dissection

Intervention Type: PROCEDURE

All patients, whose lesions are resectable and medically operable after 3 cycles neoadjuvant chemotherapy, will receive gastrectomy plus D2 lymph node dissection.

SOX adjuvant, Sequential S-1

Intervention Type: DRUG

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.

Sintilimab adjuvant

Intervention Type: DRUG

3 cycles of adjuvant immunotherapy every 21 days.

Interventions

Oxaliplatin by arterial infusion plus S-1

3 cycles oxaliplatin by arterial infusion plus S-1 every 21 days as neoadjuvant chemotherapy.

Intervention Type: DRUG

SOX neoadjuvant

3 cycles of SOX neoadjuvant chemotherapy every 21 days.

Intervention Type: DRUG

Sintilimab neoadjuvant

3 cycles of neoadjuvant immunotherapy every 21 days.

Intervention Type: DRUG

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.

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

Sintilimab adjuvant

3 cycles of adjuvant immunotherapy every 21 days.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Jian Chen

Head of Gastrointestinal Surgery, Second affiliated hospital of Zhejiang university School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gastrointestinal Department of Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shenbin XU, Doctor

Role: CONTACT

shenbin_xu@zju.edu.cn

86-15057315353

Facility Contacts

Shenbin XU, Doctor

Role: primary

shenbin_xu@zju.edu.cn

86-15057315353

Other Identifiers

ZEWC_GC_I002

Identifier Type: -

Identifier Source: org_study_id