Clinical trial NCT04500990: MRI DWI None-Gaussian Model Predicting Early Response to Immunotherapy in Digestive System Malignancies: a Prospective Observational Study
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Immunotherapy
Digestive System Neoplasm
Keywords: MRI
DWI
Digestive system malignancies
Early response
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2020-08-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receive treatment in Beijing Cancer Hospital.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Objective Response Rate
timeFrame: from enrollment of the first subject until the database cut-off approximately 12 months later.
Secondary outcomes:
measure: Progress free survival
timeFrame: from enrollment of the first subject until the database cut-off approximately 12 months later.
measure: Overall survival
timeFrame: from enrollment of the first subject until the database cut-off approximately 12 months later.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
affiliation: Peking University
name: Lin Shen, professor
role: PRINCIPAL_INVESTIGATOR
References: