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

April 7, 2021 updated by: Guohui Li

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

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, we 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.

Study Overview

Status

Recruiting

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with histologically or cytologically confirmed are prepared to receive Sintilizumab treatment

Description

Inclusion Criteria:

  1. Age ≥18 and ≤75 years old;
  2. Subjects with histologically or cytologically confirmed are prepared to receive Sintilizumab 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects with no irAEs
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.
Subjects with degree 1-2 irAEs
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.
Subjects with degree 3-4 irAEs
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
irAEs
Time Frame: 24 month
degree of irAEs induced by Sintilimab Injection
24 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 26, 2021

Primary Completion (ANTICIPATED)

December 1, 2023

Study Completion (ANTICIPATED)

October 1, 2024

Study Registration Dates

First Submitted

April 7, 2021

First Submitted That Met QC Criteria

April 7, 2021

First Posted (ACTUAL)

April 12, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 12, 2021

Last Update Submitted That Met QC Criteria

April 7, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • LC2020L03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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