Status:
UNKNOWN
MRI DWI None-Gaussian Model Predicting Early Response to Immunotherapy in Digestive System Malignancies: a Prospective Observational Study
Lead Sponsor:
Peking University
Conditions:
Immunotherapy
Digestive System Neoplasm
Eligibility:
All Genders
18+ years
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 inhib...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04500990
Start Date
September 1 2020
End Date
July 1 2021
Last Update
August 6 2020
Active Locations (1)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142