Health TrialsbyHealthPanel

The Effect of Serum Ferritin in irAE

ConditionsImmune-related Adverse EventMalignant Solid TumorsAcute LeukemiaSerum Ferritin
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

This is a prospective clinical study to clarify serum ferritin as a biomarker for the diagnosis, differential diagnosis and prognosis of immune-related adverse event(irAE).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients voluntarily sign informed consent;

The age was 18-75 years old, and the gender was not limited;

Patients with definitive diagnosis of malignant solid tumor or acute leukemia;

Patients enrolled in will be treated with immunotherapy (including immuno- monotherapy，or immuno- plus targeted therapy, or immuno- plus chemotherapy), or targeted therapy (including targeted monotherapy, or targeted plus chemotherapy), or chemotherapy.

Disqualifiers

Active systemic autoimmune disease is known before screening and is under treatment;

Those who stopped systemic hormone therapy for less than 2 weeks before enrollment；

Those who have received organ / tissue transplantation before screening;

positive for hepatitis B surface antigen (HBsAg) and / or hepatitis B e antigen (HBeAg);

Trial design

Design model

Sequential

Treatments tested in this trial

  • PD-1 and PD-L1 inhibitor

    Drug

    PD-1 inhibitor includes pembrolizumab，Nivolumab，Sintilimab，tislelizumab，Triplimab，Camrelizumab, Serplulimab. PD-L1 inhibitor includes durvalumab,Atezolizumab,Adebrelimab,Envafolimab.

  • Targeted drugs

    Drug

    Targeted drugs includes EGFR-TKIs,ALK-TKIs,Multitargeted Tyrosine Kinase Inhibitors, VEGF antibody, EGFR antibody, antibody-drug conjugates drugs

  • chemotherapy drugs

    Drug

    Chemotherapy drugs are determined based on the investigator's decision.

Treatment groups

1,500 Participants
are divided into 3 treatment groups
Group A: A: Serum ferritin in patients receiving immunotherapyExperimental treatment 3 interventions
Group B: B: Serum ferritin in patients receiving targeted therapyActive comparator 2 interventions
Group C: C: Serum ferritin in patients receiving chemotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

calculated cut-off value for serum ferritin in the diagnosis of irAE

Time frame
1 year
2

Determining the sensitivity and specificity of serum ferritin in the diagnosis of irAE

Time frame
1 year
3

Determining baseline level of serum ferritin predicts irAE occurrence

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tianjin Medical University Cancer Institute and Hospital

Lead sponsor

Source ClinicalTrials.gov
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