Actively Recruiting
Multi-Centre, Prospective, Non-Interventional Study to Intensively Monitor the Safety of Sintilimab in Clinical Practice Among Chinese Patients
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
In recent years, immunotherapy has become one of the important treatments for malignant tumors. Among them, PD-1 inhibitors have been widely used in clinical practice, and have shown a significant survival benefits in many patients. However, the incidence of immune-related adverse reactions (irAEs) of PD-1 inhibitors is relatively high, and severe cases can even threaten patients's life. At present, irAEs have become a bottleneck and it is urgent to establish a prevention strategy for the prediction of irAEs. In this study, the investigators intends to use Sintilimab as the research drug. A prospective cohort study was carried out. Part of the sample which was used as a training set would be detected for producing a time-series multi-dimensional data such as differential genes, metabolites and immune factors. Then gene expression programming (GEP) was used to explore the irAEs recognition model. Then, based on this recognition model, internal verification ( part of samples from the center 1 ) and external verification ( part of samples from the center 2 and center 3 samples) are carried out to accurately predict the high-risk population of irAEs and realize the early-stage warning of Sintilimab induced- irAEs.
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
Complete this quick 3-step screening to check your eligibility
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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