Locally Advanced Gastric CarcinomaPhase 3TACTICNCT05593458
Transarterial Neoadjuvant Chemotherapy vs.Traditional Intravenous Chemotherapy For Locally Advanced Gastric Cancer With SOX+PD-1
A Phase 3 study testing Oxaliplatin by arterial infusion plus S-1, SOX neoadjuvant and Sintilimab neoadjuvant in people with Locally Advanced Gastric Carcinoma, run by Zhejiang University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Gastric Carcinoma
- What is being tested?
- Oxaliplatin by arterial infusion plus S-1, SOX neoadjuvant and Sintilimab neoadjuvant
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to Dec 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Gastrointestinal Department of Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
Shenbin XU, Doctor, 86-15057315353, shenbin_xu@zju.edu.cn
About this study
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
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:
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- 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
- Being tested
- Oxaliplatin by arterial infusion plus S-1, SOX neoadjuvant, Sintilimab neoadjuvant, gastrectomy plus D2 lymph node dissection, SOX adjuvant, Sequential S-1
- Keywords
- gastric cancer, arterial infusion, neoadjuvant therapy, immunotherapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxaliplatin by arterial infusion plus S-1Drug
3 cycles oxaliplatin by arterial infusion plus S-1 every 21 days as neoadjuvant chemotherapy.
SOX neoadjuvantDrug
3 cycles of SOX neoadjuvant chemotherapy every 21 days.
Sintilimab neoadjuvantDrug
3 cycles of neoadjuvant immunotherapy every 21 days.
gastrectomy plus D2 lymph node dissectionProcedure or surgery
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-1Drug
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 adjuvantDrug
3 cycles of adjuvant immunotherapy every 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Arterial infusion group | Experimental | 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 Receives: 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 |
| SOX group | Active comparator | 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 Receives: Drug: SOX neoadjuvant; Drug: Sintilimab neoadjuvant; Procedure: gastrectomy plus D2 lymph node dissection; Drug: SOX adjuvant, Sequential S-1; Drug: Sintilimab adjuvant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Pathological Response rate
The percentage of people who has less than or equal to 10% residual viable tumor after neoadjuvant therapy.
Measured: 6 months
Secondary outcomes (4)
R0 resection rate
The proportion of patients with margin-free resection
Measured: 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
Measured: 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.
Measured: 2 years
pathological Complete Response rate
The percentage of people with complete disappearance of all invasive carcinoma cells.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start1 Mar 2023
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Gastric CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Chen, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593458
- Sponsor's protocol ID
- ZEWC_GC_I002
- Acronym
- TACTIC
- Status last verified
- Jun 2026
- First submitted
- 19 Oct 2022
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No