Immunotherapy Clinical Trial
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
NCT number | NCT04500990 |
Other study ID # | MRI immunotherapy |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 2020 |
Est. completion date | July 2021 |
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | July 2021 |
Est. primary completion date | July 2021 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Cancer Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | |
Secondary | 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. |
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