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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Other: there is no intervention in our study

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Wenchao Lu, Master; Phone Number: 18811183790; Email: wenchaolu621@163.com
• Study Contact Backup: Name: Zhixia Zhao, Master; Phone Number: 010-85231786; Email: zhixia.1002@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100027
      • Recruiting
      • Beijing Chao-Yang Hospital
      • Contact: Lu Wenchao, Master; Phone Number: 18811183790; Email: wenchaolu621@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

the participants make up the study population

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients without irAEs or patients with good efficacy	Other: there is no intervention in our study; there is no intervention in our study
patients with irAEs or patients with poor efficacy	Other: there is no intervention in our study; there is no intervention in our study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
immune-related adverse events incidence	November,2020-November,2025

Secondary Outcome Measures

Outcome Measure	Time Frame
Complete response (CR)	November,2020-November,2025
Partial response (PR)	November,2020-November,2025
Stable disease (SD)	November,2020-November,2025
Progressive disease (PD)	November,2020-November,2025

Collaborators and Investigators

• Sponsor: Beijing Chao Yang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2020
• Primary Completion (Anticipated): November 3, 2022
• Study Completion (Anticipated): November 3, 2025

Study Registration Dates

• First Submitted: November 18, 2020
• First Submitted That Met QC Criteria: November 30, 2020
• First Posted (Actual): December 7, 2020

Study Record Updates

• Last Update Posted (Actual): December 7, 2020
• Last Update Submitted That Met QC Criteria: November 30, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Genomics; Metabonomics; Immune checkpoint inhibitors; Immune-related adverse events
• Other Study ID Numbers: 2020-K-508

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No