- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04840355
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
Conditions
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:
- Age ≥18 and ≤75 years old;
- Subjects with histologically or cytologically confirmed are prepared to receive Sintilizumab 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
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.
Clinical Trials on PD-1
-
Merck Sharp & Dohme LLCRecruitingNon-small Cell Lung Cancer | Solid Tumors | Programmed Cell Death-1 (PD1, PD-1) | Programmed Cell Death 1 Ligand 1(PDL1, PD-L1) | Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)Japan
-
Ningbo Cancer HospitalUnknownAdvanced Malignancies | PD-1 Antibody | CAR-T CellsChina
-
Shanghai International Medical CenterUnknownAdvanced Solid Tumor | PD-1 Antibody | CAR-T CellsChina
-
University Hospital, MontpellierCompletedPatients Recieving Anti-PD-1 or Anti-PD-L1 ImmunotherapiesFrance
-
Peking UniversityNot yet recruitingGastroesophageal Junction Cancer | Chemoradiotherapy | PD-1
-
Agenus Inc.CompletedAdvanced Solid Cancers | Advanced Solid Cancers Refractory to PD-1United States
-
Sun Yat-sen UniversityRecruitingPD-1 Inhibitor | G-CSFChina
-
Beijing Friendship HospitalNot yet recruiting
-
Shandong New Time Pharmaceutical Co., LTDNot yet recruiting
Clinical Trials on Sintilimab Injection
-
Beijing Tiantan HospitalRecruiting
-
RemeGen Co., Ltd.Recruiting
-
Shanghai YingLi Pharmaceutical Co. Ltd.RecruitingAdvanced Solid TumorsChina
-
Sichuan Cancer Hospital and Research InstituteInnovent Biologics, Inc.UnknownNeoplasms | Respiratory Tract Diseases | Lung Diseases | Thoracic Neoplasms | Non-small-cell Lung Cancer
-
Shanghai Zhongshan HospitalInnovent Biologics (Suzhou) Co. Ltd.Recruiting
-
The First Hospital of Jilin UniversityActive, not recruitingIIIA Stage Non-small Cell Lung CancerChina
-
The First Affiliated Hospital with Nanjing Medical...UnknownAdvanced Hepatocellular CarcinomaChina
-
Innovent Biologics (Suzhou) Co. Ltd.CompletedAdvanced or Metastatic NSCLCChina
-
The Second Hospital of Shandong UniversityShandong Sunstem Biotechnology Co.,Ltd.Unknown
-
Innovent Biologics (Suzhou) Co. Ltd.Innovent Biologics (USA), Inc.WithdrawnMetastatic Cutaneous Melanoma | Unresectable Cutaneous MelanomaUnited States, Germany, France, Australia, Spain, Switzerland, United Kingdom