The Effect of Serum Ferritin in irAE
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
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
Treatments tested in this trial
- PD-1 and PD-L1 inhibitor
- Targeted drugs
- chemotherapy drugs
Treatment groups
1,500 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov