Prospectively Predict the Efficacy of Treatment of Gastrointestinal Tumors Based on Peripheral Multi-omics Liquid Biopsy

Study Overview
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Brief Summary
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To vertify the function of EV-score on predicting & monitoring immunotherapeutic outcomes of GC

Detailed Description
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Our previous work identified four plasma EV-derived proteins and combined them to generate a signature score that robustly predicting immunotherapeutic outcomes at baseline and dynamically monitoring disease progressions along with the whole treatment. Hence in this stuty, we plan to recruit a prospective cohort to support our conclusions, and provide possible method to realize predicting and monitoring immunotherapeutic outcomes of GC.

Official Title
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A Clinical Study Initiated by Investigator:Prospectively Predict the Efficacy of Precise Treatment of Gastrointestinal Tumors Based on Peripheral Blood Multi-omics Liquid Biopsy

Conditions
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Advanced Gastric Adenocarcinoma, Immunotherapy

Intervention / Treatment
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* Device: EV-array


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having signed informed consent Age≥ 18 years old Histologically confirmed gastric adenocarcinoma Unresectable recurrent or metastatic disease Measurable disease according to the RECIST criteria Life expectancy of ≥3 month No prior chemotherapy of the study more than 4 weeks Immunotherapy regimens were included in the treatment Exclusion Criteria: Other previous malignancy within 5 year Surgery (excluding diagnostic biopsy) within 4 weeks prior to study Pregnancy or lactation period Legal incapacity

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GC patients receiving immunotherapy<br> | Device: EV-array<br>* Collect peripheral blood sample of 40 gastric cancer patients pre-treatment. Blood samples will be transferred to central lab to detect EV-score by EV-array. Tumor response evaluation will be performed after two cycles of chemotherapy by CT/MRI based on RECIST. Clinical data, including tumor stage, metastastic organ, regimen, objective response, progression free survival, overall survival, etc, will be collected according to study protocol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EV-Score | EV-Score was calculated by the expression level of four tumor-associated proteins on plasma EV | EV-Score was detected, analysis and reported at the baseline of the treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival significance of EV-Score | Analysis patients' survival with different EV-Score. | up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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plasma-based liquid biopsy protein biomarker, extracellular vesicles, protein biomarker