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

Shen Lin40 enrolled

Overview

To vertify the function of EV-score on predicting \& monitoring immunotherapeutic outcomes of GC

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Advanced Gastric Adenocarcinoma Immunotherapy

Interventions

EV-arrayDEVICE

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.

Eligibility

Sex: ALLMin age: 18 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)

Peking University Cancer Hospital & Institute

Beijing, China

RECRUITING

Outcomes

Primary Outcomes

EV-Score

EV-Score was calculated by the expression level of four tumor-associated proteins on plasma EV

Time frame: EV-Score was detected, analysis and reported at the baseline of the treatment.

Secondary Outcomes

Survival significance of EV-Score

Analysis patients' survival with different EV-Score.

Time frame: up to 3 years

Data from ClinicalTrials.gov

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