Combining immunotherapy and chemotherapy 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 study aims to evaluate the effectiveness and safety of combining immunotherapy with chemotherapy in patients diagnosed with Borrmann type 4 or large type 3 gastric cancer. Participants will receive the anti-PD-1 inhibitor Tislelizumab along with platinum-based chemotherapy regimens in a 3-week cycle, followed by a radical surgical operation after completing six cycles of treatment. The study focuses on patients with specific histological confirmations and staging of gastric adenocarcinoma, ensuring a targeted approach to this rare cancer type.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically confirmed gastric adenocarcinoma,cT1-2N+M0 or cT3-4NanyM0;
* Males or females, aged 18-70 years;
* Gastroscopy and abdominal computed tomography (CT) scan-confirmed typical scirrhous gastric cancer (borrmann type 4) or large type 3 (over 8 cm);
* No peritoneal metastasis confirmed by laparoscopic exploration and with cytological examination of peritoneal washing of the Douglas pouch;
* ECOG performance status 0 or 1;
* Sufficient organ function:

  * white blood cell count \> 4\*10\^9/L, neutrophil cell count \> 1.5\*10\^9/L, hemoglobin \> 90 g/L, platelet count \> 100\*10\^9 /L
  * Serum bilirubin ≤ 1.5×upper limit of normal (ULN), AST, ALT ≤ 2.5×ULN
  * Creatinine ≤ 1.5 ×ULN or serum clearance \> 60 ml/min
  * INR and aPTT ≤ 1.5 × ULN, only for subjects not receiving anticoagulant therapy;Subjects undergoing coagulation therapy should use a stable dose
* No prior anti-tumor therapy;
* Have signed informed consent before the beginning of treatment.

Exclusion Criteria:

* History of another malignancy within the last five years;
* Previous cytotoxic chemotherapy, radiotherapy or immunotherapy
* Unable to take drugs orally
* Allergic to to any drug of the study regimen;
* Women who are pregnant or breastfeeding or may be pregnant

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Haibo Qiu, MD, Ph.D — Sun Yat-sen University
• Study coordinator: Haibo Qiu, MD, Ph.D
• Email: qiuhb@sysucc.org.cn
• Phone: 020-87343910

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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.