Monitoring the safety of Sintilimab in Chinese patients

Clinical Study on Multidimensional Prevention of Sintilimab Induced irAEs Based on GEP Pattern Recognition

This study is testing how safe Sintilimab is for Chinese patients by closely watching for any side effects while they receive the treatment.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Academic / other)
• Drugs / interventions: Sintilimab, immunotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT04840355 on ClinicalTrials.gov

What this trial studies

This observational study aims to intensively monitor the safety of Sintilimab, a PD-1 inhibitor, in clinical practice among Chinese patients. It will involve a prospective cohort design where patients receiving Sintilimab treatment will be observed for immune-related adverse events (irAEs). The study will utilize a training set to generate multi-dimensional data, including differential genes and immune factors, to develop a recognition model for predicting irAEs. The findings could help establish prevention strategies for these adverse reactions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with confirmed malignancies who are about to start treatment with Sintilimab.

Not a fit: Patients who have previously received immune checkpoint inhibitor treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved safety monitoring and management of immune-related adverse events in patients receiving PD-1 inhibitors.

How similar studies have performed: Other studies have shown success in monitoring immune-related adverse events with similar approaches, indicating a promising avenue for further research.

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

Where this trial is running

Beijing, Beijing Municipality

• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Recruiting)

Conditions Immune Related Adverse Events; PD-1