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

Lin Chen80 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Advanced Gastric Carcinoma Immunotherapy

Interventions

Circulating exosomal lncRNA-GC1 detectionDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Levels of circulating exosomal lncRNA-GC1

Circulating exosomal lncRNA-GC1 was detected by the RT-PCR followed by isolating exosomes.

Time frame: 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.

Time frame: Circulating exosomal lncRNA-GC1 was detected, analysis and reported through study completion, average 1 year

Secondary Outcomes

Survival outcomes of circulating exosomal lncRNA-GC1

Analysis participants' survival with different levels of circulating exosomal lncRNA-GC1 detected by RT-PCR.

Time frame: up to 3 years

Data from ClinicalTrials.gov

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