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

Plain-language summary

This is a non-interventional study that aims to closely monitor the safety of the drug Sintilimab in Chinese patients using it in clinical practice. It is open to patients aged 18-75 who are planned to receive Sintilimab treatment and have not previously received immune checkpoint inhibitor therapy. It is a non-phased study and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Recruiting

Sponsor

Guohui Li

Intervention

Sintilimab Injection

Start date

2/26/2021

Estimated completion

11/14/2025

Countries

China

Related genes

Locations

• Beijing, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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