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

• ClinicalTrials.gov Identifier: NCT04840355
• Recruitment Status: Recruiting
• First Posted: April 12, 2021
• Last Update Posted: April 12, 2021
• Sponsor: Guohui Li
• Information provided by (Responsible Party): Guohui Li, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
Immune Related Adverse Events; PD-1	Drug: Sintilimab Injection

Study Design

• Study Type: Observational
• Estimated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Clinical Study on Multidimensional Prevention of Sintilimab Induced irAEs Based on GEP Pattern Recognition
• Actual Study Start Date: February 26, 2021
• Estimated Primary Completion Date: December 1, 2023
• Estimated Study Completion Date: October 1, 2024

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. irAEs [ Time Frame: 24 month ]
   degree of irAEs induced by Sintilimab Injection

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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

Criteria

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

Contacts and Locations

Locations

China, Beijing

Cancer Hospital Chinese Academy of Medical Sciences; Recruiting

Beijing, Beijing, China, 100021

Contact: guohui Li 010-87788577 lgh0603@cicams.ac.cn

Sponsors and Collaborators

Guohui Li

More Information

• Responsible Party: Guohui Li, Pharmacy, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• ClinicalTrials.gov Identifier: NCT04840355
• Other Study ID Numbers: LC2020L03
• First Posted: April 12, 2021
• Last Update Posted: April 12, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No