Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05593458

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Gastrointestinal Department of Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location status: Recruiting

Location contact

Shenbin XU, Doctor

CONTACT

[email protected]

86-15057315353

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxaliplatin by arterial infusion plus S-1

Drug

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

SOX neoadjuvant

Drug

3 cycles of SOX neoadjuvant chemotherapy every 21 days.

Sintilimab neoadjuvant

Drug

3 cycles of neoadjuvant immunotherapy every 21 days.

gastrectomy plus D2 lymph node dissection

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

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

Drug

3 cycles of adjuvant immunotherapy every 21 days.

Primary outcomes

  1. Major Pathological Response rate

    Time frame: 6 months

    The percentage of people who has less than or equal to 10% residual viable tumor after neoadjuvant therapy.

Secondary outcomes

  1. R0 resection rate

    Time frame: 6 months

    The proportion of patients with margin-free resection

  2. 2-year Disease Free Rate

    Time frame: 2 years

    The percentage of individuals in this study who are free of the signs and symptoms of gastric cancer at 2 years after treatment

  3. 2-year Overall Survival Rate

    Time frame: 2 years

    The percentage of individuals in this study who are alive two years after their diagnosis or the start of treatment.

  4. pathological Complete Response rate

    Time frame: 6 months

    The percentage of people with complete disappearance of all invasive carcinoma cells.

Study contacts

Contact information is provided by the study sponsor or research team.

Shenbin XU, Doctor

CONTACT

[email protected]

86-15057315353

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Official study 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

Acronym: TACTIC

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 25, 2022
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.