Metabolomic and Lipidomic Analysis Predicts Immunotherapy-related Adverse Events in Gastric Cancer Patients

NCT ID: NCT06915389

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-22
• Study Completion Date: 2027-06-30

Brief 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. 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.

Conditions

Gastric Cancer; Immunotherapy; Adverse Event; Metabonomics; Lipidomics

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

No interventions assigned to this group

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)

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qinghai Red Cross Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Qinghai Red Cross Hospital

Xining, Qinghai, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Qiuxia Dong, Qiuxia Dong, Dr

Role: primary

2816278916@qq.com

0971-8267613

Other Identifiers

KY-2025-02

Identifier Type: -

Identifier Source: org_study_id