Predicting treatment response in gastric cancer using immune markers
A Prospective Cohort Study on Serum Immune Protein Signature for Predicting Neoadjuvant Therapy Efficacy in Advanced Gastric Cancer
This study is trying to find out if certain immune markers in the blood can help doctors predict how well advanced gastric cancer patients will respond to chemotherapy and immunotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 206 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai Zhongshan Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Xuhui District, Shanghai Municipality) |
| Trial ID | NCT06662110 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include males and females aged 18 to 75 with newly diagnosed histologically confirmed gastric adenocarcinoma suitable for neoadjuvant chemotherapy or combined therapy.
Not a fit: Patients with prior anti-tumor therapy for their current gastric cancer or those with serious comorbidities and a life expectancy of less than 5 years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment strategies for patients with advanced gastric cancer, improving their chances of a favorable response to therapy.
How similar studies have performed: While the approach of using immune markers for predicting treatment response is gaining traction, this specific application in gastric cancer is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Xuhui District, Shanghai Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.