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

NCT ID: NCT04656119

Last Updated: 2020-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-03

Study Completion Date

2025-11-03

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer

Keywords

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Immune checkpoint inhibitors Immune-related adverse events Genomics Metabonomics

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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patients without irAEs or patients with good efficacy

there is no intervention in our study

Intervention Type OTHER

there is no intervention in our study

patients with irAEs or patients with poor efficacy

there is no intervention in our study

Intervention Type OTHER

there is no intervention in our study

Interventions

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there is no intervention in our study

there is no intervention in our study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Chao Yang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lihong Liu

Director of Pharmacy department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Chao-yang Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wenchao Lu, Master

Role: CONTACT

Phone: 18811183790

Email: [email protected]

Zhixia Zhao, Master

Role: CONTACT

Phone: 010-85231786

Email: [email protected]

Facility Contacts

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Lu Wenchao, Master

Role: primary

Other Identifiers

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2020-K-508

Identifier Type: -

Identifier Source: org_study_id