Advanced Gastric Adenocarcinoma, Immunotherapy
Conditions
Keywords
plasma-based liquid biopsy protein biomarker, extracellular vesicles, protein biomarker
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.
Interventions
DEVICEEV-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.
Sponsors
Shen Lin
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Survival significance of EV-Score | up to 3 years | Analysis patients' survival with different EV-Score. |
Countries
China
Outcome results
None listed