Gastric Cancer Patients Received Immunotherapy
Conditions
Brief summary
We have established a machine learning model based on effective TIIC signature which could select GC patients who may benefit from immunotherapy. The current study aims to enroll 300 GC patients as a validation cohort to vertify the accuracy of TIIC signature in predicting immunotherapy efficacy
Interventions
DEVICETIIC signature
Collect tumor tissue of 300 gastric cancer patients at treatment baseline, samples will be transferred to central lab to detect the density and spatial proximity of certain immune cells infiltrated in tumor by multi complex immunohistochemistry, and evaluate patients' TIIC signature.Tumor response evaluation will be performed after two cycles of therapy by CT/MRI based on RECIST.Clinical data, including tumor stage,metastaticorgan ,regimen, objective response, progression free survival, overall survival, etc, will be collected according to study protocol.
Sponsors
Peking University
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:18-80 years old * Histologically confirmed gastric adenocarcinoma * Unresectable recurrent or metastatic gastric cancer * Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months * Measurable disease according to the RECIST criteria * Karnofsky performance status ≥70 * Life expectancy of ≥3 month * No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks * ALT and AST\<2.5 times ULN (≤5 times ULN in patients with liver metastases) * Serum albumin level ≥3.0g/dL * Serum AKP \< 2.5 times ULN * Serum creatinine \<ULN, and CCr \< 60ml/min * Bilirubin level \< 1.5 ULN * WBC\>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet\>100,000/mm3, Hb\>9g/dl
Exclusion criteria
* Previous systemic therapy for metastatic gastric cancer * Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry Contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on. * Allergic constitution or allergic history to protium biologic product or any investigating agents. * Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension. * Pregnancy or lactation period * Other previous malignancy within 5 year, except non-melanoma skin cancer * Legal incapacity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TIIC signature | Treatment baseline | Density and spatial proximity of 4 kinds of immune cells involved in TIIC signature infiltrate in tumor at treatment baseline will be recorded. |
Countries
China
Contacts
Primary ContactYang Chen, MD
Outcome results
None listed