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

Peking University

Status: Unknown

Conditions: Digestive System Neoplasm; Immunotherapy

Treatments: Radiation: MRI test

Study type: Observational

Funder types: Other

Identifiers

NCT04500990

MRI immunotherapy

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

40 participants in 2 patient groups

Single agent PD-1/PD-L1 inhibitor

Description:

Patients will receive single agent PD-1/PD-L1 inhibitor in a predefined group.

Treatment:

Radiation: MRI test

Radiation: MRI test

Radiation: MRI test

Combined immunotherapy

Description:

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.

Treatment:

Radiation: MRI test

Radiation: MRI test

Radiation: MRI test