Actively Recruiting
IMmune Proteomics to Predict neoAdjuvant Chemotherapy and immunoTherapy Response in Gastric Cancer
Led by Shanghai Zhongshan Hospital · Updated on 2024-10-28
206
Participants Needed
1
Research Sites
256 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The overall efficacy of neoadjuvant treatment for advanced gastric cancer is limited due to significant heterogeneity in patient responses. While neoadjuvant therapy offers hope for improved clinical outcomes, the key challenge is accurately predicting individual treatment responses. Identifying reliable biomarkers to guide treatment decisions is therefore critical. Immune factors are pivotal in the efficacy of gastric cancer treatment, but most research has predominantly focused on the tumor immune microenvironment. This study aims to validate the predictive value of systemic immune markers in predicting neoadjuvant treatment responses in advanced gastric cancer. Building on our previous research, where we established a retrospective cohort of patients with advanced gastric cancer undergoing preoperative chemotherapy, we employed a novel serum proteomics platform based on proximity extension assays (PEA) to measure key immune protein levels in patient serum. This led to the development of the PSRscore system, a serum immune protein score that effectively predicted tumor regression after preoperative chemotherapy (published in Cell Reports Medicine, doi: 10.1016/j.xcrm.2023.100931). In this prospective cohort study, we will enroll 166 patients with resectable advanced gastric cancer undergoing neoadjuvant chemotherapy. Baseline serum samples will be collected prior to treatment, and the PSRscore will be used to predict tumor regression. Pathological evaluation post-chemotherapy will confirm tumor response, helping to further validate and refine the PSRscore system. Additionally, an exploratory cohort of 40 patients receiving combined neoadjuvant chemotherapy and immunotherapy will be included to evaluate the correlation between PSRscore and clinical benefit from immunotherapy. This research is expected to lead to the development of a predictive diagnostic kit based on the PSRscore for advanced gastric cancer patients undergoing neoadjuvant therapy, with the ultimate goal of improving clinical decision-making and enhancing treatment outcomes for gastric cancer patients.
CONDITIONS
Official Title
IMmune Proteomics to Predict neoAdjuvant Chemotherapy and immunoTherapy Response in Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 18 to 75 years
- Newly diagnosed histologically confirmed gastric adenocarcinoma
- Tumor located in the stomach or gastroesophageal junction with clinical staging T3-4NxM0 based on the 8th edition AJCC TNM classification
- Suitable for neoadjuvant chemotherapy or chemotherapy combined with immunotherapy after multidisciplinary consultation
- Chemotherapy regimen limited to fluoropyrimidine and platinum-based drugs
- Immunotherapy regimen limited to immune checkpoint inhibitors
- Potential for curative surgery after treatment
You will not qualify if you...
- Prior anti-tumor therapy for current gastric cancer or anti-tumor drugs for other diseases within 4 weeks
- Presence of another malignancy or multiple primary tumors
- Serious comorbidities with life expectancy less than 5 years
- Severe chronic or active infections requiring systemic anti-infective therapy
- Blood transfusion within the past week
- Corticosteroid or immunosuppressive therapy within the past 2 weeks
- Live vaccine administration within the past 4 weeks
AI-Screening
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Trial Site Locations
Total: 1 location
1
Zhongshan Hospital, Fudan University
Xuhui District, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
X
Xuefei Wang
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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