Prospectively Predict the Efficacy of Treatment of Gastrointestinal Tumors Based on Peripheral Multi-omics Liquid Biopsy
NCT ID: NCT04993378
Last Updated: 2021-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
40 participants
OBSERVATIONAL
2018-11-01
2021-07-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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GC patients receiving immunotherapy
EV-array
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.
Interventions
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EV-array
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 Criteria
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Inclusion Criteria
* 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
* Surgery (excluding diagnostic biopsy) within 4 weeks prior to study
* Pregnancy or lactation period
* Legal incapacity
18 Years
ALL
No
Sponsors
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Shen Lin
OTHER
Responsible Party
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Shen Lin
Director of GI oncology Affiliation: Peking University
Locations
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Peking University Cancer Hospital & Institute
Beijing, , China
Countries
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Facility Contacts
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Other Identifiers
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CGOG-EV-1001
Identifier Type: -
Identifier Source: org_study_id
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