Clinical trial · Observational
The Correlation Between Blood Concentration of Sintilimab and Efficacy and Adverse Reactions in Patients with Advanced Gastric Cancer
Study on the Correlation Between Blood Concentration of Sintilimab and Related Predictors with Efficacy and Adverse Reactions in Patients with Advanced Gastric Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Compared with other anti-tumor drugs, immune checkpoint inhibitors (ICIs) have their own unique pharmacokinetics (PK) and pharmacodynamics (PD), and affect patient clinical outcomes. However, at present, the data on the PK and PD characteristics of ICIs in the Chinese population are still lacking, thus further clinical trials are needed to verify them. At the same time, a large proportion of patients have no response to ICIs or the efficacy is poor, and even bring greater side effects, so it is particularly important to find effective biomarkers to predict the efficacy and adverse reactions of patients with ICIs treatment.The purpose of this study is to explore the correlation between blood concentration of Sintilimab and related predictors with efficacy and adverse reactions in patients with advanced gastric cancer so as to provide clinical reference for individualized treatment of patients with gastric cancer.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer Adenocarcinoma Metastatic | — | UNRESOLVED | — |
| Gastric Carcinoma | Gastric Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Gastric (cardia, Body) Cancer | — | UNRESOLVED | — |
| Gastric Neoplasm | Gastric Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- blood concentration of Sintilimab
- timeFrame
- From February 2023 to June 2025
Secondary outcomes (5)
- measure
- the cytokines in peripheral blood
- timeFrame
- From February 2023 to June 2025
- description
- the cytokines in peripheral blood including:IL -1β, IL-2, IL-4, IL-6, IL-8, IL-10, IFN-γ, TNF-α, TNF-β
- measure
- Inflammatory biomarkers in peripheral blood
- timeFrame
- From February 2023 to June 2025
- description
- Inflammatory biomarkers in peripheral blood including:NLR, PLR, LMR/MLR, LIPI
- measure
- T lymphocyte subsets in peripheral blood
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available