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

• Conditions: Immunotherapy; Advanced Gastric Adenocarcinoma
• Interventions: Device: EV-array

• Registration Number: NCT04993378
• Lead Sponsor: Shen Lin

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2018-11-01
• Primary Completion: 2021-04-30
• Study First Submitted: 2021-07-29
• Study Completion: 2021-07-30
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-05
• Last Update Submitted: 2021-08-05
• Study First Posted: 2021-08-06
• Last Update Posted: 2021-08-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GC patients receiving immunotherapy	EV-array	-

Primary Outcome Measures

Name	Time	Method
EV-Score	EV-Score was detected, analysis and reported at the baseline of the treatment.	EV-Score was calculated by the expression level of four tumor-associated proteins on plasma EV

Secondary Outcome Measures

Name	Time	Method
Survival significance of EV-Score	up to 3 years	Analysis patients' survival with different EV-Score.

Trial Locations

Locations (1)

Peking University Cancer Hospital & Institute; 🇨🇳 Beijing, China