Combination therapy 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 evaluates the effectiveness and safety of Tislelizumab combined with apatinib, oxaliplatin, and S-1 compared to oxaliplatin and S-1 alone as neoadjuvant therapy for advanced gastric cancer. The study focuses on patients with large Borrmann III and IV types and bulky N positive tumors. Participants will undergo imaging to confirm measurable lesions and will be monitored for treatment response and safety throughout the trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age: 18-70 years of age.
* Histologically confirmed gastric adenocarcinoma was diagnosed in patients with locally advanced gastric cancer with tumor volume \>5cm Borrmann III, Borrmann IV and BulkyN according to AJCC Version 8.
* Measurable lesions at least should be detected by CT/MRI examination in accordance with the RECIST1.1.
* ECOG（Eastern Cooperative Oncology Group）PS（Performance Status）:0-1 scores.
* No previous surgical treatment, anti-tumor chemoradiotherapy/immunotherapy was performed.
* Preoperative endoscopic examination confirmed no positive peritoneal implantation metastasis and exfoliated cells.
* The expected survival time is more than 6 months.
* For women of reproductive age, a urine or serum pregnancy test with negative results should be performed within 3 days prior to receiving the first study drug administration (day 1 of cycle 1).If a urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is requested.Women of childbearing age were defined as at least 1 year after menopause or having undergone surgical sterilization or hysterectomy.

Exclusion Criteria:

* Diagnosis of malignant diseases other than gastric cancer within 5 years prior to first administration (excluding radical basal cell carcinoma of the skin, squamous carcinoma of the skin, and/or radical resectable carcinoma in situ).
* Significant clinical bleeding symptoms or clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer or vasculitis, etc. occurred within 3 months before enrollment. If fecal occult blood was positive at baseline, reexamination could be performed，if it was still positive after reexamination, gastroscopy was required.
* Prior treatment: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs that target another stimulating or co-inhibiting T-cell receptor (e.g., CTLA-4, OX-40, CD137).
* A history of immunodeficiency, including HIV testing positive.
* Is currently participating in an interventional clinical study or has been treated with another study drug or study device in the 4 weeks prior to initial dosing.
* Patients who had a history of cardiovascular and cerebrovascular diseases and were still taking thrombolytic drugs or anticoagulants orally.
* HER2 positive is known.
* Patients with previous gastrointestinal perforation, abdominal abscess or recent intestinal obstruction (within 3 months) or imaging or clinical symptoms suggesting intestinal obstruction.

Where it's running

• Fujian cancer hospital
  Fuzhou, Fujian, China Recruiting

Study contacts

• Study coordinator: chen lu chuan, bachelor
• Email: Luchuanchen@sina.cn
• Phone: 13905022862

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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.