CancerNCT04656119
Discovery of Biomarkers Related to the Efficacy and Adverse Reactions of Immune Checkpoint Inhibitors Based on Metabolism-genomics
An observational study of Cancer, run by Beijing Chao Yang Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 3 Nov 2020to 3 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the participants make up the study population
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Chao-yang Hospital
Beijing, Beijing Municipality, 100027
Lu Wenchao, Master, 18811183790, wenchaolu621@163.com
About this study
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
- Being tested
- there is no intervention in our study
- Keywords
- Immune checkpoint inhibitors, Immune-related adverse events, Genomics, Metabonomics
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
there is no intervention in our studyOther
there is no intervention in our study
| Study group | Role | What they receive |
|---|---|---|
| patients without irAEs or patients with good efficacy | Not described Receives: Other: there is no intervention in our study | |
| patients with irAEs or patients with poor efficacy | Not described Receives: Other: there is no intervention in our study |
What is being measured
The primary outcome is the main question the study is designed to answer.
immune-related adverse events incidence
Measured: November,2020-November,2025
Secondary outcomes (4)
Complete response (CR)
Measured: November,2020-November,2025
Partial response (PR)
Measured: November,2020-November,2025
Stable disease (SD)
Measured: November,2020-November,2025
Progressive disease (PD)
Measured: November,2020-November,2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start3 Nov 2020
- Primary completion3 Nov 2022 (estimated)
- Study completion3 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lihong Liu, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656119
- Sponsor's protocol ID
- 2020-K-508
- Status last verified
- Nov 2020
- First submitted
- 18 Nov 2020
- Last updated
- 7 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discovery of Biomarkers Related to the Efficacy and Adverse Reactions of Immune Checkpoint Inhibitors Based on Metabolism-genomics
- ClinicalTrials.gov ID
- NCT04656119
- Acronym / sponsor ID
- 2020-K-508
- Conditions
- Cancer
- Keywords
- Immune checkpoint inhibitors, Immune-related adverse events, Genomics, Metabonomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 3 Nov 2022 (estimated)
- Study completion
- 3 Nov 2025 (estimated)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the participants make up the study population
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| there is no intervention in our studythere is no intervention in our study | Other | patients with irAEs or patients with poor efficacy, patients without irAEs or patients with good efficacy |
Primary outcome
immune-related adverse events incidence
Time frame: November,2020-November,2025
4 secondary outcomes
Complete response (CR)
Time frame: November,2020-November,2025
Partial response (PR)
Time frame: November,2020-November,2025
Stable disease (SD)
Time frame: November,2020-November,2025
Progressive disease (PD)
Time frame: November,2020-November,2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Beijing Chao Yang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenchao Lu, Master (18811183790, wenchaolu621@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
immune-related adverse events incidence (time frame: November,2020-November,2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2020; AzTrials last refreshed its copy on 8 Nov 2026.