Multi-Centre, Prospective, Non-Interventional Study to Intensively Monitor the Safety of Sintilimab in Clinical Practice Among Chinese Patients

Launched by GUOHUI LI · Apr 7, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the safety of a medication called Sintilimab, which is used to treat certain types of cancer through immunotherapy. Immunotherapy helps the body’s immune system fight cancer, but it can sometimes cause side effects known as immune-related adverse events (irAEs). These side effects can be serious, and the goal of the study is to find ways to predict who might experience them, so that doctors can provide early warnings and better care for patients.

To participate in this trial, individuals need to be between 18 and 75 years old, have confirmed cancer that requires Sintilimab treatment, and expect to live at least six more months. They should also have certain health criteria met, such as adequate blood counts and organ function. Participants will be monitored closely for any side effects while receiving Sintilimab, and the researchers will collect data to understand how to identify those at higher risk for serious reactions. This study aims to improve safety and treatment outcomes for patients receiving immunotherapy.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 and ≤75 years old;
• • 2. Subjects with histologically or cytologically confirmed are prepared to receive Sintilimab treatment;
• • 3. Life expectancy of at least 6 months;
• • 4. Eastern Cooperative Oncology Group (ECOG) PS status≤ 2 or Karnofsky (KPS) ≥ 60;
• • 5. No prior immune checkpoint inhibitor treatment
• • 6. Signed written informed consent before any study-related procedure;
• • 7. Adequate hematopoietic function as defined by an absolute neutrophil count ≥1.5×109 /L, platelet count≥80×109 /L, hemoglobin≥90 g/L
• • 8. 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;
• • 9. Adequate renal function, defined as serum creatinine (Cr)≤1.5×ULN or calculated creatinine clearance≥60ml/min (Cockcroft-Gault formula);
• • 10. Serum albumin ≥28g/L;
• • 11. Thyroid-stimulating hormone (TSH)≤1×ULN (if abnormal,subject with the normal levels of FT3 and FT4 can be enrolled).
• Exclusion Criteria:
• • 1. Has active autoimmune disease;
• • 2. Severe heart, lung, brain, kidney, gastrointestinal or systemic diseases;
• • 3. has interstitial lung disease;
• • 4. Simultaneous use of drugs that can affect the results of this study;
• • 5. Treatment may interfere with the results of the study
• • 6. Allergy or intolerance to the study drug
• • 7. subject with unconsciousness and psychiatric disorder
• • 8. Pregnant and lactating women
• • 9. Subject with poison and alcohol abuse