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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04500990
• Other study ID #: MRI immunotherapy
• Status: Recruiting
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Digestive System Neoplasm
• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Immunotherapy
• Neoplasms

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.