Menu
Recruiting NCT04840355

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

— Observational Immune Related Adverse Events PD-1

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sintilimab Injection.
Who it may be relevant to
Registry conditions: Immune Related Adverse Events, PD-1. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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 survival benefits in many patients. However, the incidence of immune-related adverse reactions (irAEs) of PD-1 inhibitors is relatively high, and severe cases can even threaten patients's life. At present, irAEs have become a bottleneck and it is urgent to establish a prevention strategy for the prediction of irAEs. In this study, the investigators intends to use Sintilimab as the research drug. A prospective cohort study was carried out. Part of the sample which was used as a training set would be detected for producing a time-series multi-dimensional data such as differential genes, metabolites and immune factors. Then gene expression programming (GEP) was used to explore the irAEs recognition model. Then, based on this recognition model, internal verification ( part of samples from the center 1 ) and external verification ( part of samples from the center 2 and center 3 samples) are carried out to accurately predict the high-risk population of irAEs and realize the early-stage warning of Sintilimab induced- irAEs.

Interventions

  • Drug Sintilimab Injection
    The recommended dose for intravenous infusion is 200 mg on day 1.Courses repeat every 21 days for up to 6 months in the absence of disease progression or unacceptable toxicity.

Primary outcome measures

  • irAEs [Time frame: 24 month]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Cancer Hospital Chinese Academy of Medical Sciences — Beijing

Identifiers

NCT: NCT04840355 · LC2020L03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗