Actively Recruiting
Study on the Correlation Between Blood Concentration of Sintilimab and Related Predictors with Efficacy and Adverse Reactions in Patients with Advanced Gastric Cancer
Led by Lin Liu · Updated on 2024-11-25
112
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the relationship between the blood levels of Sintilimab, an immune checkpoint inhibitor, and its effects in patients with advanced gastric cancer. This research aims to better understand how Sintilimab's unique behavior in the body influences treatment results and side effects, especially since current data in the Chinese population are limited. Finding biomarkers that predict how well patients respond or react to Sintilimab is a key goal to support personalized treatment. The study involves patients with gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who are planned to receive Sintilimab treatment. Researchers will observe and collect data on the blood concentration of Sintilimab and related biological markers, including cytokines, inflammatory markers, T lymphocyte subsets, metabolic substances, and anti-drug antibodies. This observational study tracks these factors from February 2023 to June 2025 to explore their link with treatment effectiveness and side effects. Participants will undergo regular blood tests and monitoring during the study period. Researchers will evaluate the Sintilimab blood concentration as the primary measure and assess various secondary biomarkers to understand immune response and metabolism. Patients must comply with follow-up visits and examinations, and the study monitors patient outcomes and safety over time, aiming to provide useful clinical information for individualized gastric cancer treatment.
CONDITIONS
Brief Title
The Correlation Between Blood Concentration of Sintilimab and Efficacy and Adverse Reactions in Patients with Advanced Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with gastric adenocarcinoma or gastroesophageal junction adenocarcinoma
- Patients planning to be treated with Sintilimab
- ECOG performance status of 0 to 2
- Expected survival of 3 months or more
- Good compliance and ability to follow up and cooperate with treatment and examinations
- Willingness to participate and sign informed consent
You will not qualify if you...
- Incomplete clinical information or data
- Treatment with immune checkpoint inhibitors within the past 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From February 2023 to June 2025
Participants who are treated with Sintilimab are observed to study blood concentrations and related biomarkers over time.
Regular blood sample collections during treatment
Trial Site Locations
Total: 1 location
1
Zhongda Hospital Affiliated to Southeast University
Nanjing, Jiangsu, China, 210009
Actively Recruiting
Research Team
L
Lin Liu
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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