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

NCT04500990 | Unknown

• 1 other identifier: MRI immunotherapy
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Immunotherapy; Digestive System Neoplasm

Keywords

MRI; DWI; Digestive system malignancies; Early response

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Progress free survival

  from enrollment of the first subject until the database cut-off approximately 12 months later.

• Overall survival

  from enrollment of the first subject until the database cut-off approximately 12 months later.

Study Arms (2)

Single agent PD-1/PD-L1 inhibitor

Patients will receive single agent PD-1/PD-L1 inhibitor in a predefined group.

Radiation: MRI test

Combined immunotherapy

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.

Radiation: MRI test

Interventions

MRI test RADIATION

Patients will receive diagnostic MRI test on d0.

Combined immunotherapy; Single agent PD-1/PD-L1 inhibitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receive treatment in Beijing Cancer Hospital.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Digestive System Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Digestive System Diseases

Study Officials

• Lin Shen, professor

  Peking University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin Shen, professor

CONTACT

86-10-88196561; linshenpku@163.com

Lin Shen, MD PhD

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 6, 2020
• Study Start: September 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: August 6, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)