Comparing two chemotherapy methods for advanced gastric cancer

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

This study is testing a new way of giving chemotherapy for advanced stomach cancer to see if it works better than the usual method.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 190 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Zhejiang University (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT05593458 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of a novel neoadjuvant chemotherapy approach using arterial infusion of oxaliplatin combined with S-1, compared to the conventional SOX regimen for patients with locally advanced gastric cancer. Participants will be randomly assigned to receive either treatment for three cycles, followed by surgical resection and additional adjuvant chemotherapy. The study seeks to determine if the arterial infusion method provides better outcomes than traditional intravenous administration. The trial will also assess major pathological responses to the treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with histologically confirmed locally advanced gastric carcinoma and an ECOG score of 0-1.

Not a fit: Patients who cannot undergo surgical procedures or have HER2 overexpression may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a more effective neoadjuvant treatment option for patients with locally advanced gastric cancer.

How similar studies have performed: While there have been studies on neoadjuvant chemotherapy for gastric cancer, the specific approach of arterial infusion combined with S-1 is relatively novel and has not been extensively tested.

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.

Where this trial is running

Hangzhou, Zhejiang

• Gastrointestinal Department of Second Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: Shenbin XU, Doctor

Conditions: Locally Advanced Gastric Carcinoma, gastric cancer, arterial infusion, neoadjuvant therapy, immunotherapy