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

Shen Lin

Status: Unknown

Conditions: Advanced Gastric Adenocarcinoma; Immunotherapy

Treatments: Device: EV-array

Study type: Observational

Funder types: Other

Identifiers

NCT04993378

CGOG-EV-1001

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 1 patient group

GC patients receiving immunotherapy

Treatment:

Device: EV-array