NCT06702566

The Effect of Serum Ferritin in irAE

The Significance of Serum Ferritin in the Diagnosis, Differential Diagnosis, and Prognosis of Immune-related Adverse Event (irAE)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,500 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

A total of 1500 patients with definitive diagnosis of malignant solid tumor or acute leukemia will be enrolled in this study. Patients are divided into 3 groups according to the anti-tumor therapy they are to receive. Three groups will be set up, namely group A: immunotherapy group (patients will be treated with immunotherapy, or immuno- plus targeted therapy, or immuno- plus chemotherapy); group B: targeted therapy group (patients will be treated with targeted monotherapy, targeted plus chemotherapy); group C: chemotherapy group (patients will be treated with chemotherapy). All patients received blood biochemistry and imaging at baseline, and adverse events were monitored. If a patient in the immunotherapy group presents with an AE, the AE is diagnosed by a multi-disciplinary MDT team including oncologists, rheumatologists, immunologists, respiratory pathologists, radiologists, and pathologists, and further diagnosed as irAE or non-irAE. All patients underwent hematologic testing every 3 days (at least 3 times) after the onset of AE including: blood routine examination, ferritin, CRP, D-dimer, and cytokines (IL-1β, IL-6, and TNF-α)until recovery from AE. Patients without AE will re-testing of baseline blood biochemistry every 4 treatment cycles.

Conditions

• Immune-related Adverse Event
• Malignant Solid Tumors
• Acute Leukemia
• Serum Ferritin

Interventions

Type	Name	Description
DRUG	PD-1 and PD-L1 inhibitor	PD-1 inhibitor includes pembrolizumab，Nivolumab，Sintilimab，tislelizumab，Triplimab，Camrelizumab, Serplulimab. PD-L1 inhibitor includes durvalumab,Atezolizumab,Adebrelimab,Envafolimab.
DRUG	Targeted drugs	Targeted drugs includes EGFR-TKIs,ALK-TKIs,Multitargeted Tyrosine Kinase Inhibitors, VEGF antibody, EGFR antibody, antibody-drug conjugates drugs
DRUG	chemotherapy drugs	Chemotherapy drugs are determined based on the investigator's decision.

Timeline

• Start date: 2024-07-04
• Primary completion: 2026-07-16
• Completion: 2027-07-01
• First posted: 2024-11-25
• Last updated: 2024-11-25

Locations

1 site across 1 country: China