NCT05593458 Transarterial Neoadjuvant Chemotherapy vs.Traditional Intravenous Chemotherapy For Locally Advanced Gastric Cancer With SOX+PD-1
| NCT ID | NCT05593458 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Zhejiang University |
| Condition | Locally Advanced Gastric Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 190 participants |
| Start Date | 2023-03-01 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 190 participants in total. It began in 2023-03-01 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05593458 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Locally Advanced Gastric Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05593458 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 190 participants.
Is NCT05593458 currently recruiting?
Yes, NCT05593458 is actively recruiting participants. Contact the research team at shenbin_xu@zju.edu.cn for enrollment information.
Where is the NCT05593458 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT05593458 clinical trial?
NCT05593458 is sponsored by Zhejiang University. The trial plans to enroll 190 participants.