Status:
RECRUITING
Multi-Centre, Prospective, Non-Interventional Study to Intensively Monitor the Safety of Sintilimab in Clinical Practice Among Chinese Patients
Lead Sponsor:
Guohui Li
Conditions:
Immune Related Adverse Events
PD-1
Eligibility:
All Genders
18-75 years
Brief Summary
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 sur...
Eligibility Criteria
Inclusion
- Age ≥18 and ≤75 years old;
- Subjects with histologically or cytologically confirmed are prepared to receive Sintilimab treatment;
- Life expectancy of at least 6 months;
- Eastern Cooperative Oncology Group (ECOG) PS status≤ 2 or Karnofsky (KPS) ≥ 60;
- No prior immune checkpoint inhibitor treatment
- Signed written informed consent before any study-related procedure;
- Adequate hematopoietic function as defined by an absolute neutrophil count ≥1.5×109 /L, platelet count≥80×109 /L, hemoglobin≥90 g/L
- Adequate hepatic function, defined as a total bilirubin level≤1.5 ×upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤2.5 × ULN in subjects without liver metastases, AST and ALT levels ≤5 × ULN in subjects with documented liver metastases;
- Adequate renal function, defined as serum creatinine (Cr)≤1.5×ULN or calculated creatinine clearance≥60ml/min (Cockcroft-Gault formula);
- Serum albumin ≥28g/L;
- Thyroid-stimulating hormone (TSH)≤1×ULN (if abnormal,subject with the normal levels of FT3 and FT4 can be enrolled).
Exclusion
- Has active autoimmune disease;
- Severe heart, lung, brain, kidney, gastrointestinal or systemic diseases;
- has interstitial lung disease;
- Simultaneous use of drugs that can affect the results of this study;
- Treatment may interfere with the results of the study
- Allergy or intolerance to the study drug
- subject with unconsciousness and psychiatric disorder
- Pregnant and lactating women
- Subject with poison and alcohol abuse
Key Trial Info
Start Date :
February 26 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 14 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04840355
Start Date
February 26 2021
End Date
November 14 2025
Last Update
December 27 2024
Active Locations (1)
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1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021