Prospectively Predict the Immunotherapy Response of Gastric Cancer Based on Circulating Exosomal LncRNA-GC1 Biopsy

Study Overview
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Brief Summary
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To vertify the function of circulating exosomal lncRNA-GC1 on predicting and monitoring immunotherapeutic outcomes of GC

Detailed Description
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The investigator's previous work identified circulating exosomal lncRNA-GC1 as a GC-specific tumor burden marker and this novel biomarker showed promising efficiency in monitoring disease progression during treatment. Hence in this stuty, the investigator plan to recruit a prospective cohort to support the conclusions, and provide biomarkers to realize predicting and monitoring immunotherapeutic outcomes of GC.

Official Title
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Prospectively Predict the Efficacy of Precise Immunotherapy Response of Gastric Cancer Based on Circulating Exosomal LncRNA-GC1 Biopsy

Conditions
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Advanced Gastric Carcinoma, Immunotherapy

Intervention / Treatment
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* Device: Circulating exosomal lncRNA-GC1 detection


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
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

| Intervention/Treatment |
| --- |
|Device: Circulating exosomal lncRNA-GC1 detection|Collect peripheral blood sample of 80 gastric cancer patients pre-treatment. Blood samples will be transferred to central lab to detect circulating exosomal lncRNA-GC1. Tumor response evaluation will be performed after two cycles of immunotherapy 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of circulating exosomal lncRNA-GC1 | Circulating exosomal lncRNA-GC1 was detected by the RT-PCR followed by isolating exosomes. | Circulating exosomal lncRNA-GC1 was detected, analysis and reported at the baseline | 
| Levels of circulating exosomal lncRNA-GC1 | Circulating exosomal lncRNA-GC1 was detected by the RT-PCR followed by isolating exosomes. | Circulating exosomal lncRNA-GC1 was detected, analysis and reported through study completion, average 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival outcomes of circulating exosomal lncRNA-GC1 | Analysis participants' survival with different levels of circulating exosomal lncRNA-GC1 detected by RT-PCR. | up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Circulating exosomal lncRNA-GC1, Advanced Gastric Carcinoma, Immunotherapy response