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

Peking University

Status: Enrolling

Conditions: Gastric Cancer Patients Received Immunotherapy

Treatments: Device: TIIC signature

Study type: Observational

Funder types: Other

Identifiers

NCT05593419

CGOG-GMAP 1.0

Details and patient eligibility

About

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

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 1 patient group

Immunotherapy Group

Treatment:

Device: TIIC signature