Examining the relationship between Sintilimab levels and treatment outcomes in advanced gastric cancer patients
Study on the Correlation Between Blood Concentration of Sintilimab and Related Predictors with Efficacy and Adverse Reactions in Patients with Advanced Gastric Cancer
This study is testing how the levels of Sintilimab in the blood affect treatment results and side effects for people with advanced gastric cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 112 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zhongda Hospital Academic / other |
| Drugs / interventions | Sintilimab |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06702683 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate how the blood concentration of Sintilimab, an immune checkpoint inhibitor, correlates with treatment efficacy and adverse reactions in patients diagnosed with advanced gastric cancer. The study focuses on identifying effective biomarkers that can predict patient responses to Sintilimab, addressing the current lack of pharmacokinetic and pharmacodynamic data in the Chinese population. By analyzing these correlations, the research seeks to provide clinical insights for personalized treatment strategies in gastric cancer management.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who are planning to receive Sintilimab treatment.
Not a fit: Patients who have received immune checkpoint inhibitors within the last six months or have incomplete clinical information may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and tailored treatment options for patients with advanced gastric cancer.
How similar studies have performed: While this approach is novel in the context of the Chinese population, similar studies in other regions have shown promise in correlating drug levels with treatment outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: A. Patients who were diagnosed with gastric adenocarcinoma or gastroesophageal junction adenocarcinoma; B. Patients who plan to be treated with Sintilimab; C.ECOG score of 0-2; D. Expected survival ≥3 months; E. The patient who have good compliance, follow-up, and can cooperate with relevant treatment and examination; F. Agree to participate in the study and sign the informed consent Exclusion Criteria: A. Patients who clinical information and data are incomplete; B. Patients who treated with immune checkpoint inhibitors within 6 months
Where this trial is running
Nanjing, Jiangsu
- Zhongda Hospital Affiliated to Southeast University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Lin Liu
- Email: 101012478@seu.edu.cn
- Phone: +86 13913968688
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.