Multiplex immune profiling reveals the role of serum immune proteomics in predicting response to preoperative chemotherapy of gastric cancer.
Zhaoqing Tang, Yuan Gu, Zhongyi Shi...
https://pubmed.ncbi.nlm.nih.gov/36724786Actively Recruiting
Age: 18Years - 75Years
All Genders
ID06662110
A Prospective Cohort Study on Serum Immune Protein Signature for Predicting Neoadjuvant Therapy Efficacy in Advanced Gastric Cancer
Led by Shanghai Zhongshan Hospital · Updated on 2024-10-28
206
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how well systemic immune markers can predict responses to neoadjuvant treatments in patients with advanced gastric cancer. The study focuses on the PSRscore, a serum immune protein score developed to forecast tumor regression after preoperative chemotherapy. This prospective cohort study builds on earlier research that used a novel serum proteomics platform to measure immune proteins, aiming to improve treatment decision-making for advanced gastric cancer patients. The study will enroll 166 patients with resectable advanced gastric cancer undergoing neoadjuvant chemotherapy, primarily using the SOX regimen as standard care. Additionally, an exploratory group of 40 patients receiving combined neoadjuvant chemotherapy and immunotherapy will be included to assess the PSRscore's ability to predict clinical benefits from immunotherapy. Baseline serum samples will be collected before treatment to calculate the PSRscore, which will then be compared with pathological tumor regression after chemotherapy. Participants will have their tumor response evaluated through pathological examination following neoadjuvant therapy, with ongoing monitoring of treatment outcomes including progression-free and overall survival for up to five years. The primary outcome is the accuracy of the PSRscore in predicting tumor regression, measured from enrollment until completion of pathological assessment, averaging about two years. This study aims to develop a predictive diagnostic kit based on the PSRscore to better guide neoadjuvant therapies for gastric cancer patients.
CONDITIONS
Brief Title
IMmune Proteomics to Predict neoAdjuvant Chemotherapy and immunoTherapy Response in Gastric Cancer
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Males or females aged 18 to 75 years
- Newly diagnosed histologically confirmed gastric adenocarcinoma
- Lesion located in the stomach or gastroesophageal junction with clinical staging of T3-4NxM0
- Suitable for neoadjuvant chemotherapy or neoadjuvant chemotherapy combined with immunotherapy after multidisciplinary consultation
- Chemotherapy limited to fluoropyrimidine and platinum-based systemic chemotherapy
- Immunotherapy limited to immune checkpoint inhibitors
You will not qualify if you...
- Prior anti-tumor therapy for current gastric cancer or anti-tumor drugs for other conditions 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
- Use of corticosteroid or immunosuppressive therapy within 2 weeks
- Receipt of a live vaccine within 4 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 4 weeks
Participants undergo baseline serum immune proteomics testing to calculate the PSRscore before starting neoadjuvant therapy.
1 visit (in-person)
Monitoring
Duration - Approximately 2 years
Participants receiving neoadjuvant chemotherapy or neoadjuvant chemotherapy plus immunotherapy are observed during and after treatment according to standard clinical practice.
Visits as per routine clinical care
Long-term Monitoring
Duration - Up to 5 years
Participants are followed for progression-free and overall survival outcomes after completion of neoadjuvant treatment.
Periodic visits during follow-up
Trial Site Locations
Total: 1 location
1
Zhongshan Hospital, Fudan University
Xuhui District, Shanghai Municipality, China, 200032
Actively Recruiting
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Research Team
X
Xuefei Wang
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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