Predicting treatment response in gastric cancer using immune markers

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 observational study aims to identify reliable biomarkers that can predict individual responses to neoadjuvant chemotherapy and immunotherapy in patients with advanced gastric cancer. By utilizing a novel serum proteomics platform based on proximity extension assays, the study will measure key immune protein levels in patient serum. The goal is to validate the predictive value of these systemic immune markers, which could enhance treatment decision-making and improve clinical outcomes for patients. The study builds on previous research involving a cohort of patients undergoing preoperative chemotherapy.

Why it matters

Who can join: the full rules

Inclusion Criteria

1. Males or females aged 18 to 75 years;
2. Newly diagnosed histologically confirmed gastric adenocarcinoma;
3. Lesion located in the stomach or gastroesophageal junction as assessed by endoscopic ultrasound and enhanced CT, with clinical staging of T3-4NxM0 (based on the 8th edition of AJCC TNM classification);
4. Determined suitable for neoadjuvant chemotherapy or neoadjuvant chemotherapy combined with immunotherapy after multidisciplinary consultation, with potential for curative resection post-treatment. The chemotherapy regimen is restricted to fluoropyrimidine and platinum-based systemic chemotherapy; the immunotherapy regimen is restricted to immune checkpoint inhibitors.

Exclusion Criteria

1. Prior receipt of any anti-tumor therapy for current gastric cancer or receipt of anti-tumor drugs for other conditions within the past 4 weeks;
2. Presence of another malignancy or multiple primary tumors;
3. Serious comorbidities with a life expectancy of less than 5 years;
4. Severe chronic or active infections requiring systemic anti-infective therapy;
5. Blood transfusion within the past week;
6. Receipt of corticosteroid or immunosuppressive therapy within the past 2 weeks;
7. Administration of a live vaccine within the past 4 weeks.

Where it's running

• Zhongshan Hospital, Fudan University
  Xuhui District, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Xuefei Wang — Fudan University
• Study coordinator: Xuefei Wang
• Email: wang.xuefei@zs-hospital.sh.cn
• Phone: + 86 21 64041990

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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.