The Correlation Between Blood Concentration of Sintilimab and Efficacy and Adverse Reactions in Patients with Advanced Gastric Cancer

NCT ID: NCT06702683

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 112 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-17
• Study Completion Date: 2025-12-31

Brief Summary

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

Gastric Carcinoma; Gastric Neoplasm; Gastric (cardia, Body) Cancer; Gastric Cancer Adenocarcinoma Metastatic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lin Liu

OTHER

Sponsor Role: lead

Responsible Party

Lin Liu

Chief physician of Oncology Department

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Zhongda Hospital Affiliated to Southeast University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lin Liu

Role: CONTACT

101012478@seu.edu.cn

+86 13913968688

Facility Contacts

Lin Liu

Role: primary

101012478@seu.edu.cn

+86 13913968688

Other Identifiers

2022ZDSYLL329-P01

Identifier Type: -

Identifier Source: org_study_id