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

Inclusion criteria

• 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 criteria

• 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