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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04656119
• Other study ID #: 2020-K-508
• Status: Recruiting
• Start date: November 3, 2020
• Est. completion date: November 3, 2025

Study information

• Verified date: November 2020
• Source: Beijing Chao Yang Hospital
• Contact: Wenchao Lu, Master
• Phone: 18811183790
• Email: wenchaolu621[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 3, 2025
• Est. primary completion date: November 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• there is no intervention in our study
there is no intervention in our study

Locations

Country	Name	City	State
China	Beijing Chao-yang Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	immune-related adverse events incidence		November,2020-November,2025
Secondary	Complete response (CR)		November,2020-November,2025
Secondary	Partial response (PR)		November,2020-November,2025
Secondary	Stable disease (SD)		November,2020-November,2025
Secondary	Progressive disease (PD)		November,2020-November,2025