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

Sponsor

Peking University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05593419

Collaborator

(none)

300

Enrollment

Location

Anticipated Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer Patients Received Immunotherapy	Device: TIIC signature

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Oct 31, 2022

Anticipated Primary Completion Date :

Oct 31, 2025

Anticipated Study Completion Date :

Oct 31, 2025

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University Cancer Hospital	Beijing		China

Sponsors and Collaborators

Peking University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shen Lin, Professor, Peking University

ClinicalTrials.gov Identifier:

NCT05593419

Other Study ID Numbers:

CGOG-GMAP 1.0

First Posted:

Oct 25, 2022

Last Update Posted:

Oct 25, 2022

Last Verified:

Oct 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Stomach Neoplasms

Study Results

No Results Posted as of Oct 25, 2022