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Clinical Trials/NCT04656119
NCT04656119
Recruiting
Not Applicable

Discovery of Biomarkers Related to the Efficacy and Adverse Reactions of Immune Checkpoint Inhibitors Based on Metabolism-genomics

Beijing Chao Yang Hospital1 site in 1 country100 target enrollmentNovember 3, 2020
ConditionsCancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer
Sponsor
Beijing Chao Yang Hospital
Enrollment
100
Locations
1
Primary Endpoint
immune-related adverse events incidence
Status
Recruiting
Last Updated
5 years ago

Overview

Brief Summary

Immune checkpoint inhibitors (ICIs) are an important breakthrough in cancer therapy and have been increasingly used.However, ICIs can cause a unique spectrum of side effects termed immune-related adverse events (irAEs),which can affect any organ systems and in some cases are fulminant or even fatal.In clinical practice, irAEs and clinical efficacy maybe various for patients with same standard treatment, and some studies have shown that gene and metabolic differences in cancer patients may be an important factor. In this project, peripheral blood samples from cancer patients will be collected prospectively at baseline, and at regular intervals (2 cycles, about 6 weeks) for about 30 weeks, then these blood samples will be analyzed using the technique of genomics, metabonomics.

The investigators aim to find biomarkers associated with irAE or clinical efficacy. When the sample size and data is big enough, the investigators plan to establish a prediction model using machine learning to access the safety and efficacy of ICIs for cancer patients. Our study have important clinical implications in the prediction and early management of severe, potentially life-threatening immune-related toxicity.

Registry
clinicaltrials.gov
Start Date
November 3, 2020
End Date
November 3, 2025
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Beijing Chao Yang Hospital
Responsible Party
Principal Investigator
Principal Investigator

Lihong Liu

Director of Pharmacy department

Beijing Chao Yang Hospital

Eligibility Criteria

Inclusion Criteria

  • Histologically confirmed malignant tumor, no relative contraindications for immunotherapy, in line with the standards of immunotherapy
  • Receive immune checkpoint inhibitors (ICIs) for the first time or have received ICIs but no immune-related adverse reactions have occurred
  • Have provided informed consent, are willing to participate in study and routine follow-up
  • At least one measurable lesion according to Guidelines for response criteria for use in trials testing immunotherapeutics (iRECIST)

Exclusion Criteria

  • Active, known, suspected or a documented history of autoimmune disease
  • Eastern Cooperative Oncology Group(ECOG) performance status 3-4
  • Long-term hormone therapy,corticosteroids (\>10mg/day prednisone curative dose)
  • Subjects with human immunodeficiency virus (HIV)
  • Subjects with other tumors
  • Myocardial infarction, poorly control led arrhythmia, New York Heart Association (NYHA) standard III-IV cardiac insufficiency or left ventricular ejection fraction (LVEF)\<50% in the last 6 month
  • Active tuberculosis
  • Active or a documented history of interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severely impaired lung function
  • Common Terminology Criteria for Adverse Events (CTCAE) peripheral neuropathy grade≥2
  • History of alcohol abuse

Outcomes

Primary Outcomes

immune-related adverse events incidence

Time Frame: November,2020-November,2025

Secondary Outcomes

  • Complete response (CR)(November,2020-November,2025)
  • Stable disease (SD)(November,2020-November,2025)
  • Progressive disease (PD)(November,2020-November,2025)
  • Partial response (PR)(November,2020-November,2025)

Study Sites (1)

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