MRI DWI None-Gaussian Model Predicting Early Response to Immunotherapy in Digestive System Malignancies: a Prospective Observational Study

Study Overview
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Brief Summary
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This is a prospective two cohorts observational study aimed to investigate the predicting value of MRI none-Gaussian model in digestive malignancies patients who received single agent PD-1/PD-L1 inhibitor or combined immunotherapy.

Official Title
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Magnetic Resonance Imaging (MRI) Diffusion-weighted Imaging (Dwi) None-Gaussian Model Predicting Early Response to Immunotherapy in Digestive System Malignancies: a Prospective Observational Study

Conditions
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Immunotherapy, Digestive System Neoplasm

Intervention / Treatment
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* Radiation: MRI test
* Radiation: MRI test
* Radiation: MRI test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥ 18 years, ECOG 0-1, expected survival ≥3 months; pathologically confirmed digestive system adenocarcinoma, including but not restricted to gastric adenocarcinoma, colorectal cancer, pancreatic adenocarcinoma et al; pathologically confirmed PD-L1 expression, or MMR-deficient (dMMR)/microsatellite instability (MSI-H) or high tumor mutation burden (TMB-H) or other indication for immunotherapy; at least one target lesion, if there is no target lesion the thickness of cavity viscera lesion should exceed 1cm; patients will receive single agent PD-1/PD-L1 inhibitor, or combined immunotherapy such as: lenvatinib, enrotinib or herceptin; screening laboratory values must meet the following criteria: hemoglobin ≥ 9.0 g/dL; neutrophils ≥ 1500 cells/ μL; platelets ≥ 100 x 10^3/ μL; total bilirubin ≤ 2.0 x upper limit of normal (ULN); aspartic transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN without, and ≤ 5 x ULN with hepatic metastasis; serum creatinine ≤1.5 x ULN, and serum creatinine rate >50μmol/L; activated partial thromboplastin time (APTT)、international normalized ratio (INR), prothrombin lime (PT)≤1.5×ULN; echocardiography: left ventricular ejection fraction≥50% volunteer participate, signed written informed consent form. Exclusion Criteria: claustrophobia or other contraindication for MRI testing; received prior anti-PD-1/PD-L1 or other immune checkpoint inhibitors; combined immunotherapy contains chemotherapy agent; contain other histology component except adenocarcinoma； hypersensitivity after other monoclonal antibody infusion； coexist other malignancy in last five years; active autoimmune disease, or who received systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 2 weeks of first dose; Cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) are not well controlled, and need locally treatment or repeated drainage; obvious bleeding tendency or had CTCAE≥3 grade； subjects are eligible with clinically controlled and stable neurologic function ≥ 4 weeks, which is no evidence of CNS disease progression; subjects with spinal cord compression and cancerous meningitis are not eligible； vaccination within 28 days of the first administration of trial treatment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single agent PD-1/PD-L1 inhibitor<br>Patients will receive single agent PD-1/PD-L1 inhibitor in a predefined group. | Radiation: MRI test<br>* Patients will receive diagnostic MRI test on d0.<br>Radiation: MRI test<br>* Patients will receive diagnostic MRI test on d8±1.<br>Radiation: MRI test<br>* Patients will receive diagnostic MRI test on d30±2.<br>|
| Combined immunotherapy<br>Patients will receive combined immunotherapy in a predefined group. PD-1/PD-L1 inhibitor will be combined with target therapy, such as lenvatinib, enrotinib, herceptin et al. | Radiation: MRI test<br>* Patients will receive diagnostic MRI test on d0.<br>Radiation: MRI test<br>* Patients will receive diagnostic MRI test on d8±1.<br>Radiation: MRI test<br>* Patients will receive diagnostic MRI test on d30±2.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate | The rate of patients reached complete response or partial response. | from enrollment of the first subject until the database cut-off approximately 12 months later. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress free survival | the time from enrollment to disease progression or death or loss of follow-up. | from enrollment of the first subject until the database cut-off approximately 12 months later. | 
| Overall survival | the time from enrollment to death or loss of follow-up. | from enrollment of the first subject until the database cut-off approximately 12 months later. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI, DWI, Digestive system malignancies, Early response