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

NCT04656119 | Unknown DMC

• 1 other identifier: 2020-K-508
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Immune checkpoint inhibitors; Immune-related adverse events; Genomics; Metabonomics

Outcome Measures

Primary Outcomes (1)

• immune-related adverse events incidence

  November,2020-November,2025

Secondary Outcomes (4)

• 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

Study Arms (2)

patients without irAEs or patients with good efficacy

Other: there is no intervention in our study

patients with irAEs or patients with poor efficacy

Other: there is no intervention in our study

Interventions

there is no intervention in our study OTHER

there is no intervention in our study

patients with irAEs or patients with poor efficacy; patients without irAEs or patients with good efficacy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

the participants make up the study population

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

Study Sites (1)

Beijing Chao-yang Hospital

Beijing, Beijing Municipality, 100027, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Wenchao Lu, Master

CONTACT

18811183790; wenchaolu621@163.com

Zhixia Zhao, Master

CONTACT

010-85231786; zhixia.1002@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Pharmacy department

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: December 7, 2020
• Study Start: November 3, 2020
• Primary Completion: November 3, 2022
• Study Completion: November 3, 2025
• Last Updated: December 7, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)