Selecting Patients Who May Benefit From Immunotherapy by Tissue-based Biomarkers.

Study Overview
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Brief Summary
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We have established a machine learning model based on effective TIIC signature which could select GC patients who may benefit from immunotherapy. The current study aims to enroll 300 GC patients as a validation cohort to vertify the accuracy of TIIC signature in predicting immunotherapy efficacy

Official Title
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Selecting Patients Who May Benefit From Immunotherapy by Tissue-based Biomarkers

Conditions
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Gastric Cancer Patients Received Immunotherapy

Intervention / Treatment
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* Device: TIIC signature


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having signed informed consent Age:18-80 years old Histologically confirmed gastric adenocarcinoma Unresectable recurrent or metastatic gastric cancer Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months Measurable disease according to the RECIST criteria Karnofsky performance status ≥70 Life expectancy of ≥3 month No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks ALT and AST<2.5 times ULN (≤5 times ULN in patients with liver metastases) Serum albumin level ≥3.0g/dL Serum AKP < 2.5 times ULN Serum creatinine <ULN, and CCr < 60ml/min Bilirubin level < 1.5 ULN WBC>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet>100,000/mm3, Hb>9g/dl Exclusion Criteria: Previous systemic therapy for metastatic gastric cancer Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry Contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on. Allergic constitution or allergic history to protium biologic product or any investigating agents. Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension. Pregnancy or lactation period Other previous malignancy within 5 year, except non-melanoma skin cancer Legal incapacity

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Immunotherapy Group<br> | Device: TIIC signature<br>* Collect tumor tissue of 300 gastric cancer patients at treatment baseline, samples will be transferred to central lab to detect the density and spatial proximity of certain immune cells infiltrated in tumor by multi complex immunohistochemistry, and evaluate patients' TIIC signature.Tumor response evaluation will be performed after two cycles of therapy by CT/MRI based on RECIST.Clinical data, including tumor stage,metastaticorgan ,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 |
| --- | --- | --- |
| TIIC signature | Density and spatial proximity of 4 kinds of immune cells involved in TIIC signature infiltrate in tumor at treatment baseline will be recorded. | Treatment baseline |