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

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

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.

Study Overview

• Status: Unknown
• Conditions: Digestive System Neoplasm; Immunotherapy
• Intervention / Treatment: Radiation: MRI test; Radiation: MRI test; Radiation: MRI test

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Lin Shen, MD PhD

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Beijing Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients receive treatment in Beijing Cancer Hospital.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single agent PD-1/PD-L1 inhibitor; Patients will receive single agent PD-1/PD-L1 inhibitor in a predefined group.	Radiation: MRI test; Patients will receive diagnostic MRI test on d0.; Radiation: MRI test; Patients will receive diagnostic MRI test on d8±1.; Radiation: MRI test; Patients will receive diagnostic MRI test on d30±2.
Combined immunotherapy; 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; Patients will receive diagnostic MRI test on d0.; Radiation: MRI test; Patients will receive diagnostic MRI test on d8±1.; Radiation: MRI test; Patients will receive diagnostic MRI test on d30±2.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Peking University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: July 30, 2020
• First Submitted That Met QC Criteria: August 4, 2020
• First Posted (Actual): August 6, 2020

Study Record Updates

• Last Update Posted (Actual): August 6, 2020
• Last Update Submitted That Met QC Criteria: August 4, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: MRI; DWI; Digestive system malignancies; Early response
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Site; Gastrointestinal Diseases; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms
• Other Study ID Numbers: MRI immunotherapy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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