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

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

NCT ID: NCT05593419

Condition: Gastric Cancer Patients Received Immunotherapy

Conditions: Official terms:
Stomach Neoplasms

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Device
Intervention name: TIIC signature
Description: 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.
Arm group label: Immunotherapy Group

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

Criteria for eligibility:

Study pop:
All patients in this study were enrolled by the Department of gastrointestinal oncology, Peking University Cancer Hospital & Institute for conventional therapy or clinical trials

Sampling method: Probability Sample
Criteria:
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 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

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Peking University Cancer Hospital

Address:
City: Beijing
Country: China

Status: Recruiting

Contact:
Last name: Lin Shen, MD

Phone: 010-88196561
Email: linshenpku@163.com

Start date: October 31, 2022

Completion date: October 31, 2025

Lead sponsor:
Agency: Peking University
Agency class: Other

Source: Peking University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05593419