Actively Recruiting
Study of Sintilimab Immune Side Effect Prevention Using Gene Expression Patterns Prospective Observational Safety Monitoring in Patients Receiving Sintilimab
Led by Guohui Li · Updated on 2024-12-27
100
Participants Needed
1
Research Sites
246 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety of Sintilimab, a PD-1 inhibitor used in immunotherapy for malignant tumors, focusing on immune-related adverse events (irAEs) that can be severe and life-threatening. The study aims to develop a prediction model for these adverse reactions using gene expression programming (GEP) and multi-dimensional data like gene differences, metabolites, and immune factors. This prospective cohort study involves internal and external validation to identify patients at high risk of irAEs and provide early warnings during Sintilimab treatment. Participants will receive Sintilimab injections at a dose of 200 mg via intravenous infusion on day 1 of each 21-day cycle, continuing for up to 6 months unless the disease progresses or unacceptable toxicity occurs. The study collects time-series data from a subset of participants to build and verify the irAEs recognition model. The validation includes samples from multiple centers to ensure accuracy in predicting high-risk patients. Throughout the study, participants will be closely monitored for safety, including assessments of immune-related adverse events over 24 months. Researchers will evaluate blood counts, liver and kidney function, thyroid hormones, and overall health status. Participants must have adequate organ function and good performance status to join. The study will track and analyze data to help establish better prevention strategies for irAEs related to Sintilimab therapy.
CONDITIONS
Official Title
Multi-Centre, Prospective, Non-Interventional Study to Intensively Monitor the Safety of Sintilimab in Clinical Practice Among Chinese Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years old
- Histologically or cytologically confirmed patients prepared to receive Sintilimab treatment
- Life expectancy of at least 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status 2 or less, or Karnofsky score 60 or higher
- No prior immune checkpoint inhibitor treatment
- Signed written informed consent before any study procedure
- Adequate blood cell counts: neutrophils ≥1.5×10⁹/L, platelets ≥80×10⁹/L, hemoglobin ≥90 g/L
- Adequate liver function: total bilirubin ≤1.5× upper limit of normal (ULN); AST and ALT ≤2.5× ULN without liver metastases or ≤5× ULN with liver metastases
- Adequate kidney function: serum creatinine ≤1.5× ULN or creatinine clearance ≥60 ml/min
- Serum albumin ≥28 g/L
- Thyroid-stimulating hormone ≤1× ULN (if abnormal, normal FT3 and FT4 levels required)
You will not qualify if you...
- Active autoimmune disease
- Severe heart, lung, brain, kidney, gastrointestinal, or systemic diseases
- Interstitial lung disease
- Use of drugs that may affect the study results
- Treatments that could interfere with study results
- Allergy or intolerance to Sintilimab
- Unconsciousness or psychiatric disorders
- Pregnant or breastfeeding women
- History of poison or alcohol abuse
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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