NCT05593419

Selecting Patients Who May Benefit From Immunotherapy by Tissue-based Biomarkers.

Selecting Patients Who May Benefit From Immunotherapy by Tissue-based Biomarkers

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Gastric Cancer Patients Received Immunotherapy

Interventions

Type	Name	Description
DEVICE	TIIC 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.

Timeline

• Start date: 2022-10-31
• Primary completion: 2025-10-31
• Completion: 2025-10-31
• First posted: 2022-10-25
• Last updated: 2022-10-25

Locations

1 site across 1 country: China