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

• Conditions: Immunotherapy; Digestive System Neoplasm
• Interventions: Radiation: MRI test

• Registration Number: NCT04500990
• Lead Sponsor: Peking University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-07-30
• Study First Submitted QC: 2020-08-04
• Last Update Submitted: 2020-08-04
• Study First Posted: 2020-08-06
• Last Update Posted: 2020-08-06
• Study Start: 2020-09
• Primary Completion: 2021-07
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Combined immunotherapy	MRI test	Patients will receive combined immunotherapy in a predefined group. PD-1/PD-L1 inhibitor will be combined with target therapy, such as lenvatinib, enrotinib, herceptin et al.
Single agent PD-1/PD-L1 inhibitor	MRI test	Patients will receive single agent PD-1/PD-L1 inhibitor in a predefined group.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate	from enrollment of the first subject until the database cut-off approximately 12 months later.	The rate of patients reached complete response or partial response.

Secondary Outcome Measures

Name	Time	Method
Progress free survival	from enrollment of the first subject until the database cut-off approximately 12 months later.	the time from enrollment to disease progression or death or loss of follow-up.
Overall survival	from enrollment of the first subject until the database cut-off approximately 12 months later.	the time from enrollment to death or loss of follow-up.

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China