Gastric CancerNCT06915389
Metabolomic and Lipidomic Analysis Predicts Immunotherapy-related Adverse Events in Gastric Cancer Patients
An observational study of Gastric Cancer and Immunotherapy, run by Qinghai Red Cross Hospital at 1 site in China.
Trial summary
This study comprehensively examines metabolic and lipidomic dynamics in gastric cancer patients initiating PD-1/PD-L1 inhibitor therapy, employing a longitudinal design with pre- and post-treatment patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer, Immunotherapy, Adverse Event
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 22 Feb 2025to 30 Jun 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All the research subjects were patients with gastric cancer who were aged ≥ 18 years, had ECOG score ranging from 0 to 2, were confirmed by pathology, and received either anti-PD-L1/anti-PD-1 monotherapy or combination chemotherapy, with an expected survival period of ≥ 3 months
Who may be able to join
- Age≥ 18 years
- ECOG PS 0-2
- Gastric cancer diagnosed by histology or cytology
- Untreatment with PD-1/PD-L1 inhibitors
- Expected survival≥3 months
- Exhibits a favorable adherence to treatment and follow-up,demonstrates compliance with the research protocol, and willingly signs the informed consent form.
Who cannot join
- Unable to obtain an organization or due to insufficient organizational material, unable to diagnose gastric cancer
- Refusal to receive PD-1/PD-L1 inhibitor treatment
- Baseline (before immunotherapy) plasma samples are unavailable
- Combined with autoimmune diseases
- Baseline (before immunotherapy) there are severe diseases in the heart, lungs, thyroid gland and other organs
- Baseline (before immunotherapy) there are severe abnormalities in liver and kidney functions, pancreatic enzymes and other indicators
- ⑦ Researchers posit that any condition deemed potentially harmful to the subjects or that might prevent subjects from meeting or adhering to the research requirements shall not be permissible for inclusion in this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Qinghai Red Cross Hospital
Xining, Qinghai, 810000
Qiuxia Dong, Qiuxia Dong, Dr, 0971-8267613, 2816278916@qq.com
About this study
Official title: Comprehensive Plasma Metabolomic and Lipidomic Profiling for Predictive Modeling and Biomarker Discovery of Immune-Related Adverse Events in PD-1/PD-L1 Inhibitor-Treated Gastric Cancer Patients: A Prospective Cohort Study
This study comprehensively examines metabolic and lipidomic dynamics in gastric cancer patients initiating PD-1/PD-L1 inhibitor therapy, employing a longitudinal design with pre- and post-treatment patients. The primary objectives include identifying irAE-associated metabolic and lipid biomarkers, developing predictive risk models, and evaluating the prognostic value of these molecular profiles. The findings are expected to contribute significantly to personalized treatment strategies and improved clinical decision-making in immunooncology.
Read the detailed description
This study is designed as a prospective clinical trial employing advanced metabolomics and lipidomics methodologies to comprehensively analyze alterations in metabolites and lipid molecules within plasma samples. The primary objective is to investigate the differential profiles between gastric cancer patients who induce immune-related adverse events (irAEs) and who not, following Programmed Cell Death Protein 1/Programmed Death-Ligand 1 inhibitor(PD-1/PD-L1 inhibitor) therapy. Through this approach, the investigators aim to establish predictive biomarkers for irAEs occurrence and subsequently develop a robust prognostic model to enhance clinical management and therapeutic outcomes. Patients who meet the inclusion and exclusion criteria will be formally enrolled after screening and signing an informed consent form. Patients pathologically confirmed of gastric cancer who received anti-PD-1/anti-PD-L1 blockade therapy alone or with combined with chemotherapy. Baseline plasma samples were collected before immune checkpoint inhibitors(ICIs) treatment for all patients. Patients with irAEs collected plasma samples at the onset of irAEs, and patients without irAEs collected samples according to the treatment cycles to onset of irAEs patients. Patients with irAEs and without irAEs were matched by 1:1 or 1:2 for consideration of age, sex and stage to confirm the sample of which cycle should be chosen for patients without irAEs. Comprehensive metabolomics and lipidomics analyses were performed on the collected plasma samples,Differential metabolites and lipid molecules related to immune-related adverse events were screened out.By leveraging the identified key metabolites and lipid molecules, a robust predictive model has been developed to evaluate the risk of immune-related adverse events in patients. Comprehensive data on quality-of-life metrics and adverse event severity grading were systematically collected for patients experiencing immune-related adverse events. Extended analyses were carried out to evaluate potential links between the identified metabolic/lipidomic signatures and long-term patient prognosis.
- Conditions
- Gastric Cancer, Immunotherapy, Adverse Event, Metabonomics, Lipidomics
- Keywords
- Immune-related adverse events (irAEs), PD-1/PD-L1 inhibitors, Gastric cancer, Biomarkers, Metabolic, Lipidomic
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Immune-related adverse events（irAEs）group | Integrated metabolomic and lipidomic profiling was conducted to delineate the differential metabolic signatures and lipidomic alterations prior to PD-1/PD-L1 inhibitor therapy initiation and throughout the progression of immune-related adverse events (irAEs) | |
| Non-Immune-related adverse events (Non-irAEs) group | Integrated metabolomic and lipidomic profiling was conducted to delineate the differential metabolic signatures and lipidomic alterations prior to PD-1/PD-L1 inhibitor therapy initiation and throughout the progression of immune-related adverse events (irAEs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of immune-related adverse events
- For gastric cancer patients receiving immunotherapy for the first time, immune-related adverse events should be monitored during treatment, with a follow-up period of 1 year.
- The immune checkpoint inhibitors include pembrolizumab, nivolumab, sintilimab, tislelizumab, sugemalimab and camrelizumab.
- NCCN Guidelines for Management of Immunotherapy-Related Toxicity are adopted as the gold standard for assessing immune-related adverse events.
- The severity of immune-related adverse events was evaluated based on the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
Measured: 1 year
Changes in Plasma Metabolite Levels
- A comprehensive metabolomic profiling of plasma in treatment-naïve gastric cancer patients undergoing immunotherapy: Investigating metabolic disparities between responders with immune-related adverse events and those without.
- The measurement methods include gas chromatography-mass spectrometry (GC-MS) and liquid chromatography-mass spectrometry (LC-MS).
- The measured metabolites include amino acids, fatty acids, glucose, lactate, nucleotides, organic acids, vitamins and small-molecule metabolites.
- All metabolomic markers in plasma will be reported as relative quantitative values in arbitrary units.
- Baseline plasma samples were collected from all patients prior to immunotherapy, and follow-up samples were obtained every 2 treatment cycles until 1 year after treatment initiation.
Measured: 1 year
Changes in Plasma Lipid Levels
- Comprehensive lipidomic profiling of plasma from gastric cancer patients undergoing initial immunotherapy was performed to investigate differential plasma lipid signatures between those who developed immune-related adverse events and those who did not.
- The measurement methods include gas chromatography-mass spectrometry (GC-MS) and liquid chromatography-mass spectrometry (LC-MS).
- The measured lipids include triglycerides, cholesterol, phospholipids, fatty acids, ceramides, steroids, fatty acid derivatives, and other sphingolipids.
- All plasma lipidomic markers will be reported as relative quantitative values in arbitrary units.
- Baseline plasma samples were collected from all patients prior to immunotherapy, with subsequent samples obtained every 2 treatment cycles until 1 year of therapy.
Measured: 1 year
Secondary outcomes (2)
Develop a predictive model for immune-related adverse events
- This predictive model incorporates input variables including lipid molecules, metabolites, and baseline clinical characteristics of patients, with the output being an adverse event risk score (low, intermediate, or high risk).
- Employing machine learning algorithms (e.g., logistic regression, random forests, support vector machines) to construct predictive models.
- The clinical characteristics include age (reported in years), height and weight (reported as BMI in kg/m²), gender (recorded as male or female), tumor stage (classified by TNM staging system).
- The measured metabolites include amino acids, fatty acids, glucose, lactate, nucleotides, organic acids, vitamins and small-molecule metabolites.
- The measured lipids include triglycerides, cholesterol, phospholipids, fatty acids, ceramides, steroids, fatty acid derivatives, and other sphingolipids.
- All metabolomic and lipidomics markers in plasma will be reported as relative quantitative values in arbitrary units.
Measured: 2 years
Investigating the correlation between metabolomic and lipidomic profiles and patient outcomes to inform evidence-based clinical decision-making.
Using survival analysis (e.g., Kaplan-Meier curves, Cox regression models) to assess the association between Immune-related adverse events and patient survival rates or recurrence rates
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start22 Feb 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Qinghai Red Cross Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06915389
- Sponsor's protocol ID
- KY-2025-02
- Status last verified
- Feb 2025
- First submitted
- 25 Feb 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Plasma Metabolomic and Lipidomic Profiling for Predictive Modeling and Biomarker Discovery of Immune-Related Adverse Events in PD-1/PD-L1 Inhibitor-Treated Gastric Cancer Patients: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06915389
- Acronym / sponsor ID
- KY-2025-02
- Conditions
- Gastric Cancer, Immunotherapy, Adverse Event, Metabonomics, Lipidomics
- Keywords
- Immune-related adverse events (irAEs), PD-1/PD-L1 inhibitors, Gastric cancer, Biomarkers, Metabolic, Lipidomic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Qinghai Red Cross HospitalUniversity, hospital or other
- Study start
- 22 Feb 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 8 Apr 2025 (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.
This study comprehensively examines metabolic and lipidomic dynamics in gastric cancer patients initiating PD-1/PD-L1 inhibitor therapy, employing a longitudinal design with pre- and post-treatment patients. The primary objectives include identifying irAE-associated metabolic and lipid biomarkers, developing predictive risk models, and evaluating the prognostic value of these molecular profiles. The findings are expected to contribute significantly to personalized treatment strategies and improved clinical decision-making in immunooncology.
Detailed description
This study is designed as a prospective clinical trial employing advanced metabolomics and lipidomics methodologies to comprehensively analyze alterations in metabolites and lipid molecules within plasma samples. The primary objective is to investigate the differential profiles between gastric cancer patients who induce immune-related adverse events (irAEs) and who not, following Programmed Cell Death Protein 1/Programmed Death-Ligand 1 inhibitor(PD-1/PD-L1 inhibitor) therapy. Through this approach, the investigators aim to establish predictive biomarkers for irAEs occurrence and subsequently develop a robust prognostic model to enhance clinical management and therapeutic outcomes. Patients who meet the inclusion and exclusion criteria will be formally enrolled after screening and signing an informed consent form. Patients pathologically confirmed of gastric cancer who received anti-PD-1/anti-PD-L1 blockade therapy alone or with combined with chemotherapy. Baseline plasma samples were collected before immune checkpoint inhibitors(ICIs) treatment for all patients. Patients with irAEs collected plasma samples at the onset of irAEs, and patients without irAEs collected samples according to the treatment cycles to onset of irAEs patients. Patients with irAEs and without irAEs were matched by 1:1 or 1:2 for consideration of age, sex and stage to confirm the sample of which cycle should be chosen for patients without irAEs. Comprehensive metabolomics and lipidomics analyses were performed on the collected plasma samples,Differential metabolites and lipid molecules related to immune-related adverse events were screened out.By leveraging the identified key metabolites and lipid molecules, a robust predictive model has been developed to evaluate the risk of immune-related adverse events in patients. Comprehensive data on quality-of-life metrics and adverse event severity grading were systematically collected for patients experiencing immune-related adverse events. Extended analyses were carried out to evaluate potential links between the identified metabolic/lipidomic signatures and long-term patient prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immune-related adverse events（irAEs）group | – | –Integrated metabolomic and lipidomic profiling was conducted to delineate the differential metabolic signatures and lipidomic alterations prior to PD-1/PD-L1 inhibitor therapy initiation and throughout the progression of immune-related adverse events (irAEs) |
| Non-Immune-related adverse events (Non-irAEs) group | – | –Integrated metabolomic and lipidomic profiling was conducted to delineate the differential metabolic signatures and lipidomic alterations prior to PD-1/PD-L1 inhibitor therapy initiation and throughout the progression of immune-related adverse events (irAEs) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the research subjects were patients with gastric cancer who were aged ≥ 18 years, had ECOG score ranging from 0 to 2, were confirmed by pathology, and received either anti-PD-L1/anti-PD-1 monotherapy or combination chemotherapy, with an expected survival period of ≥ 3 months
Key inclusion criteria (6 listed)
- Age≥ 18 years
Key exclusion criteria (7 listed)
- Unable to obtain an organization or due to insufficient organizational material, unable to diagnose gastric cancer
- ⑦ Researchers posit that any condition deemed potentially harmful to the subjects or that might prevent subjects from meeting or adhering to the research requirements shall not be permissible for inclusion in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of immune-related adverse events
Time frame: 1 year
* For gastric cancer patients receiving immunotherapy for the first time, immune-related adverse events should be monitored during treatment, with a follow-up period of 1 year. * The immune checkpoint inhibitors include pembrolizumab, nivolumab, sintilimab, tislelizumab, sugemalimab and camrelizumab. * NCCN Guidelines for Management of Immunotherapy-Related Toxicity are adopted as the gold standard for assessing immune-related adverse events. * The severity of immune-related adverse events was evaluated based on the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
Changes in Plasma Metabolite Levels
Time frame: 1 year
* A comprehensive metabolomic profiling of plasma in treatment-naïve gastric cancer patients undergoing immunotherapy: Investigating metabolic disparities between responders with immune-related adverse events and those without. * The measurement methods include gas chromatography-mass spectrometry (GC-MS) and liquid chromatography-mass spectrometry (LC-MS). * The measured metabolites include amino acids, fatty acids, glucose, lactate, nucleotides, organic acids, vitamins and small-molecule metabolites. * All metabolomic markers in plasma will be reported as relative quantitative values in arbitrary units. * Baseline plasma samples were collected from all patients prior to immunotherapy, and follow-up samples were obtained every 2 treatment cycles until 1 year after treatment initiation.
Changes in Plasma Lipid Levels
Time frame: 1 year
* Comprehensive lipidomic profiling of plasma from gastric cancer patients undergoing initial immunotherapy was performed to investigate differential plasma lipid signatures between those who developed immune-related adverse events and those who did not. * The measurement methods include gas chromatography-mass spectrometry (GC-MS) and liquid chromatography-mass spectrometry (LC-MS). * The measured lipids include triglycerides, cholesterol, phospholipids, fatty acids, ceramides, steroids, fatty acid derivatives, and other sphingolipids. * All plasma lipidomic markers will be reported as relative quantitative values in arbitrary units. * Baseline plasma samples were collected from all patients prior to immunotherapy, with subsequent samples obtained every 2 treatment cycles until 1 year of therapy.
2 secondary outcomes
Develop a predictive model for immune-related adverse events
Time frame: 2 years
Investigating the correlation between metabolomic and lipidomic profiles and patient outcomes to inform evidence-based clinical decision-making.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
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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.
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 Gastric Cancer and Immunotherapy, run by Qinghai Red Cross 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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 8 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of immune-related adverse events (time frame: 1 year). The study lists 3 primary outcomes in all. 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 8 Apr 2025.