NCT06702683 The Correlation Between Blood Concentration of Sintilimab and Efficacy and Adverse Reactions in Patients with Advanced Gastric Cancer
| NCT ID | NCT06702683 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Lin Liu |
| Condition | Gastric Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 112 participants |
| Start Date | 2023-02-17 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 112 participants in total. It began in 2023-02-17 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06702683 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastric Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06702683 currently recruiting?
Yes, NCT06702683 is actively recruiting participants. Contact the research team at 101012478@seu.edu.cn for enrollment information.
Where is the NCT06702683 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT06702683 clinical trial?
NCT06702683 is sponsored by Lin Liu. The trial plans to enroll 112 participants.