Examining the relationship between Sintilimab levels and treatment outcomes in advanced gastric cancer patients
Official title: Study on the Correlation Between Blood Concentration of Sintilimab and Related Predictors with Efficacy and Adverse Reactions in Patients with Advanced Gastric Cancer
Run by Zhongda Hospital · NCT06702683 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 112 (estimated) |
| Sponsor | Zhongda Hospital Academic / other |
| Drugs / interventions | Sintilimab |
| Locations | 1 site (Nanjing, Jiangsu) |
| Status | Recruiting |
| Started | February 17, 2023 |
| Main results expected | June 30, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | November 25, 2024 |
| Trial ID | NCT06702683 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients diagnosed with gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who are planning to receive Sintilimab treatment.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Zhongda Hospital Affiliated to Southeast University
Nanjing, Jiangsu, China Recruiting
Study contacts
- Study coordinator: Lin Liu
- Email: 101012478@seu.edu.cn
- Phone: +86 13913968688
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.