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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date July 2020
Source Peking University
Contact Lin Shen, professor
Phone 86-10-88196561
Email linshenpku@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design


Intervention

Radiation:
MRI test
Patients will receive diagnostic MRI test on d0.
MRI test
Patients will receive diagnostic MRI test on d8±1.
MRI test
Patients will receive diagnostic MRI test on d30±2.

Locations

Country Name City State
China Beijing Cancer Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

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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