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

Sponsor

Peking University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04500990

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Immunotherapy Digestive System Neoplasm	Radiation: MRI test Radiation: MRI test Radiation: MRI test

Study Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2020

Anticipated Primary Completion Date :

Jul 1, 2021

Anticipated Study Completion Date :

Jul 1, 2021

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Objective Response Rate [from enrollment of the first subject until the database cut-off approximately 12 months later.]
The rate of patients reached complete response or partial response.

Secondary Outcome Measures

Progress free survival [from enrollment of the first subject until the database cut-off approximately 12 months later.]
the time from enrollment to disease progression or death or loss of follow-up.
Overall survival [from enrollment of the first subject until the database cut-off approximately 12 months later.]
the time from enrollment to death or loss of follow-up.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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.