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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04993378
Other study ID # CGOG-EV-1001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2018
Est. completion date July 30, 2021

Study information

Verified date August 2021
Source Peking University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date July 30, 2021
Est. primary completion date April 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Device:
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.

Locations

Country Name City State
China Peking University Cancer Hospital & Institute Beijing

Sponsors (1)

Lead Sponsor Collaborator
Shen Lin

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary EV-Score EV-Score was calculated by the expression level of four tumor-associated proteins on plasma EV EV-Score was detected, analysis and reported at the baseline of the treatment.
Secondary Survival significance of EV-Score Analysis patients' survival with different EV-Score. up to 3 years
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