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

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

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

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer Patients Received Immunotherapy
• Intervention / Treatment: Device: TIIC signature

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Yang Chen, MD; Phone Number: 010-88196090; Email: yang_chen@bjcancer.org

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking University Cancer Hospital
    • Contact: Lin Shen, MD; Phone Number: 010-88196561; Email: linshenpku@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Immunotherapy Group

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TIIC signature	Density and spatial proximity of 4 kinds of immune cells involved in TIIC signature infiltrate in tumor at treatment baseline will be recorded.	Treatment baseline

Collaborators and Investigators

• Sponsor: Peking University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 31, 2022
• Primary Completion (Anticipated): October 31, 2025
• Study Completion (Anticipated): October 31, 2025

Study Registration Dates

• First Submitted: October 21, 2022
• First Submitted That Met QC Criteria: October 21, 2022
• First Posted (Actual): October 25, 2022

Study Record Updates

• Last Update Posted (Actual): October 25, 2022
• Last Update Submitted That Met QC Criteria: October 21, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: CGOG-GMAP 1.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No