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

Launched by QINGHAI RED CROSS HOSPITAL · Apr 3, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating how certain substances in the body, known as metabolites and lipids, can help predict side effects in patients with gastric cancer who are starting a specific type of treatment called immunotherapy. Immunotherapy works by helping the body's immune system fight cancer, but it can sometimes cause unwanted reactions, known as adverse events. The study aims to find out if measuring these substances before and after treatment can identify patients at higher risk for these side effects. Researchers hope that this information will lead to more personalized treatment plans and better decision-making for doctors.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of gastric cancer. They should not have received immunotherapy treatment before and must expected to live for at least three more months. Participants will need to agree to follow the study guidelines and provide consent. Those who have serious health problems or other conditions that could interfere with the study will not be able to participate. If you join this trial, you can expect to provide blood samples before and after starting immunotherapy, and your health will be closely monitored throughout the study.

Gender

ALL

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