Clinical trial · Observational
Selecting Patients Who May Benefit From Immunotherapy by Tissue-based Biomarkers.
Selecting Patients Who May Benefit From Immunotherapy by Tissue-based Biomarkers
NCT05593419CI-TRIAL-00061674unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer Patients Received Immunotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TIIC signature | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Immunotherapy Group
- interventionNames
- Device: TIIC signature
Primary outcomes (1)
- measure
- TIIC signature
- timeFrame
- Treatment baseline
- description
- Density and spatial proximity of 4 kinds of immune cells involved in TIIC signature infiltrate in tumor at treatment baseline will be recorded.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.