Advanced Gastric Carcinoma, Immunotherapy
Conditions
Keywords
Circulating exosomal lncRNA-GC1, Advanced Gastric Carcinoma, Immunotherapy response
Brief summary
To vertify the function of circulating exosomal lncRNA-GC1 on predicting and monitoring immunotherapeutic outcomes of GC
Detailed description
The investigator's previous work identified circulating exosomal lncRNA-GC1 as a GC-specific tumor burden marker and this novel biomarker showed promising efficiency in monitoring disease progression during treatment. Hence in this stuty, the investigator plan to recruit a prospective cohort to support the conclusions, and provide biomarkers to realize predicting and monitoring immunotherapeutic outcomes of GC.
Interventions
DEVICECirculating exosomal lncRNA-GC1 detection
Collect peripheral blood sample of 80 gastric cancer patients pre-treatment. Blood samples will be transferred to central lab to detect circulating exosomal lncRNA-GC1. Tumor response evaluation will be performed after two cycles of immunotherapy 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
Lin Chen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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 |
|---|---|---|
| Levels of circulating exosomal lncRNA-GC1 | Circulating exosomal lncRNA-GC1 was detected, analysis and reported at the baseline | Circulating exosomal lncRNA-GC1 was detected by the RT-PCR followed by isolating exosomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival outcomes of circulating exosomal lncRNA-GC1 | up to 3 years | Analysis participants' survival with different levels of circulating exosomal lncRNA-GC1 detected by RT-PCR. |
Countries
China
Outcome results
None listed