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Study on the correlation between blood concentration of Sintilimab and related predictors with 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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500096945
Enrollment
Unknown
Registered
2025-02-10
Start date
2023-02-17
Completion date
Unknown
Last updated
2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric cancer

Interventions

the group of using Sintilimab for the first-line treatment:NA
the group of using Sintilimab for the second-line and above treatment:NA

Sponsors

Zhongda Hospital Affiliated to Southeast University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

Exclusion criteria: A. Patients whose clinical information and data are incomplete; B. Patients who treated with immune checkpoint inhibitors within 6 months.

Design outcomes

Primary

MeasureTime frame
blood concentration of Sintilimab;

Secondary

MeasureTime frame
the cytokines in peripheral blood:IL-1ß;the cytokines in peripheral blood:IL-2;the cytokines in peripheral blood:IL-4;the cytokines in peripheral blood:IL-6;the cytokines in peripheral blood:IL-8;the cytokines in peripheral blood:IL-10;the cytokines in peripheral blood:IFN-?;the cytokines in peripheral blood:TNF-a;the cytokines in peripheral blood:TNF-ß;inflammatory biomarkers in peripheral blood:NLR;inflammatory biomarkers in peripheral blood:PLR;inflammatory biomarkers in peripheral blood:LMR/MLR;inflammatory biomarkers in peripheral blood:LIPI;T lymphocyte subsets:CD4;T lymphocyte subsets:CD8;T lymphocyte subsets:Th1;T lymphocyte subsets:Th9;T lymphocyte subsets:Th17;fatty acid and bile acid metabolism:ursodeoxycholic acid;fatty acid and bile acid metabolism:short-chain fatty acid;fatty acid and bile acid metabolism:polyunsaturated fatty acids;anti-drug antibody;

Countries

China

Contacts

Public ContactLin Liu

Zhongda Hospital Affiliated to Southeast University

101012478@seu.edu.cn+86 139 1396 8688

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026