Clinical trial NCT04656119: Discovery of Biomarkers Related to the Efficacy and Adverse Reactions of Immune Checkpoint Inhibitors Based on Metabolism-genomics
Official title: Discovery of Biomarkers Related to the Efficacy and Adverse Reactions of Immune Checkpoint Inhibitors Based on Metabolism-genomics
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Keywords: Immune checkpoint inhibitors
Immune-related adverse events
Genomics
Metabonomics
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2020-12-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the participants make up the study population

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.


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

Primary outcomes:
measure: immune-related adverse events incidence
timeFrame: November,2020-November,2025
Secondary outcomes:
measure: Complete response (CR)
timeFrame: November,2020-November,2025
measure: Partial response (PR)
timeFrame: November,2020-November,2025
measure: Stable disease (SD)
timeFrame: November,2020-November,2025
measure: Progressive disease (PD)
timeFrame: November,2020-November,2025
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chao-yang Hospital
state: Beijing
Study officials:
References: