RecruitingNCT05593458TACTICUpdated Jun 11, 2026

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

A Phase 3 interventional study of Oxaliplatin by arterial infusion plus S-1 and SOX neoadjuvant in Locally Advanced Gastric Carcinoma, sponsored by Zhejiang University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-11.

Sponsored by Zhejiang University · Phase 3, Interventional, and Treatment

From the registry’s dates

Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
Started Mar 2023; still recruiting 3 years 7 months later.

Phase: Phase 3
Study type: Interventional
Enrollment: 190
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study 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 studied

Locally Advanced Gastric Carcinoma

Browse trials for

Stomach Neoplasms 2,851

Keywords

gastric cancer
arterial infusion
neoadjuvant therapy
immunotherapy

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's planned enrollment of 190 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Zhejiang University is the lead sponsor of 351 studies on the registry; 165 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 190 participants (estimated)

Study arms

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
Drug: Oxaliplatin by arterial infusion plus S-1 · Drug: Sintilimab neoadjuvant · Procedure: gastrectomy plus D2 lymph node dissection · Drug: SOX adjuvant, Sequential S-1 · Drug: Sintilimab adjuvant
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
Drug: SOX neoadjuvant · Drug: Sintilimab neoadjuvant · Procedure: gastrectomy plus D2 lymph node dissection · Drug: SOX adjuvant, Sequential S-1 · Drug: Sintilimab adjuvant

Interventions

DrugOxaliplatin by arterial infusion plus S-1
3 cycles oxaliplatin by arterial infusion plus S-1 every 21 days as neoadjuvant chemotherapy.
DrugSOX neoadjuvant
3 cycles of SOX neoadjuvant chemotherapy every 21 days.
DrugSintilimab neoadjuvant
3 cycles of neoadjuvant immunotherapy every 21 days.
Proceduregastrectomy 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.
DrugSOX 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.
DrugSintilimab adjuvant
3 cycles of adjuvant immunotherapy every 21 days.

What researchers measure

Primary outcomes

Major Pathological Response rate
The percentage of people who has less than or equal to 10% residual viable tumor after neoadjuvant therapy.
Time frame: 6 months

Secondary outcomes

R0 resection rate
The proportion of patients with margin-free resection
Time frame: 6 months
2-year Disease Free Rate
The percentage of individuals in this study who are free of the signs and symptoms of gastric cancer at 2 years after treatment
Time frame: 2 years
2-year Overall Survival Rate
The percentage of individuals in this study who are alive two years after their diagnosis or the start of treatment.
Time frame: 2 years
pathological Complete Response rate
The percentage of people with complete disappearance of all invasive carcinoma cells.
Time frame: 6 months

Study locations

1 of 1 sites recruiting

Gastrointestinal Department of Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang 310000, China
- Shenbin XU, Doctor · Contact · shenbin_xu@zju.edu.cn · 86-15057315353
Recruiting

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05593458
Lead sponsor: Zhejiang University
Responsible party: Jian Chen (Head of Gastrointestinal Surgery, Second affiliated hospital of Zhejiang university School of Medicine, Zhejiang University) — Principal investigator
First posted: Oct 25, 2022
Start date: Mar 1, 2023
Primary completion: Jun 2026 (estimated)
Completion: Dec 2026 (estimated)
Last update: Jun 11, 2026

Study contacts

Shenbin XU, Doctor

Contact

shenbin_xu@zju.edu.cn

86-15057315353

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Stomach Neoplasms→

Other studies from this sponsor

Zhejiang University

Start the discussion