Comparing two chemotherapy methods for advanced gastric cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Gastrointestinal Department of Second Affiliated Hospital of Zhejiang University
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Shenbin XU, Doctor
• Email: shenbin_xu@zju.edu.cn
• Phone: 86-15057315353

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using immunotherapy and chemotherapy for advanced gastric cancer treatment

  This study is testing if combining immunotherapy with chemotherapy can help people with advanced gastric cancer feel better and improve their treatment outcomes.

  Recruiting Qilu Hospital of Shandong University · Jinan, Shandong · NCT06727981

• Combining two anticancer drugs for treating advanced gastric and gastroesophageal junction cancers

  This study is testing a new combination of two cancer drugs to see if they can help people with advanced HER2-positive gastric or gastroesophageal junction cancers feel better and live longer.

  Recruiting Phase 1 National Cancer Institute (NCI) · Houston, Texas · NCT06364410

• Using olanzapine to help cancer patients regain appetite and manage weight loss

  This study is testing if the medication olanzapine can help cancer patients who are losing weight and have a poor appetite feel better and gain weight while they are receiving treatment.

  Recruiting Phase 2 OHSU Knight Cancer Institute · Portland, Oregon · NCT05705492

• Combining toripalimab with chemotherapy for advanced gastric cancer

  This study is testing if combining a new drug called toripalimab with chemotherapy can help people with advanced stomach cancer do better before surgery.

  Recruiting Phase 2 Henan Cancer Hospital · Zhengzhou, Henan · NCT04891016

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.