The Effect of Serum Ferritin in irAE

NCT06702566 | Recruiting DMC

• 1 other identifier: E20240619
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

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

Outcome Measures

Primary Outcomes (3)

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

  1 year

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

  1 year

• Determining baseline level of serum ferritin predicts irAE occurrence

  1 year

Study Arms (3)

A: Serum ferritin in patients receiving immunotherapy

EXPERIMENTAL

Patients will receive standardized anti-tumor therapy including immunotherapy according to clinical guidelines. Patients who treated with immuno-monotherapy, or immuno- plus targeted therapy, or immuno- plus chemotherapy will be recruit in to test the serum ferritin level

Drug: PD-1 and PD-L1 inhibitor; Drug: Targeted drugs; Drug: chemotherapy drugs

B: Serum ferritin in patients receiving targeted therapy

ACTIVE COMPARATOR

Patients will receive standardized anti-tumor therapy including targeted therapy according to clinical guidelines. Patients who treated with targeted monotherapy, or targeted plus chemotherapy will be recruit in to test the serum ferritin level

Drug: Targeted drugs; Drug: chemotherapy drugs

C: Serum ferritin in patients receiving chemotherapy

ACTIVE COMPARATOR

Patients will receive standardized anti-tumor therapy including chemotherapy according to clinical guidelines. Patients who treated with chemotherapy will be recruit in to test the serum ferritin level

Drug: chemotherapy drugs

Interventions

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.

A: Serum ferritin in patients receiving immunotherapy

Targeted drugs DRUG

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

A: Serum ferritin in patients receiving immunotherapy; B: Serum ferritin in patients receiving targeted therapy

chemotherapy drugs DRUG

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

A: Serum ferritin in patients receiving immunotherapy; B: Serum ferritin in patients receiving targeted therapy; C: Serum ferritin in patients receiving chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Only patient who meet all the following conditions can be selected for this trial:
• 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.
• The Eastern Cooperative Oncology Group (ECOG) scored 0 or 1 or 2 for physical fitness;
• Sufficient bone marrow reserve at screening, defined as:
• Neutrophil absolute value (ANC) \> 1.5 × 10\^9/L；
• Lymphocyte absolute value (ALC) ≥ 0.3 × 10\^9/L；
• Platelet (PLT) ≥ 100 × 10\^9/L；
• Hemoglobin (HGB) ≥ 100g / L;
• The screening has appropriate organ function and meets the following criteria:
• Aspartate aminotransferase (AST) ≤ 2.5 times ULN (due to tumor infiltration ≤ 5 times ULN);
• Alanine aminotransferase (ALT) ≤ 2.5 times ULN (due to tumor infiltration ≤ 5 times ULN);
• Total serum bilirubin ≤ 1.5 times ULN (due to tumor infiltration ≤ 3 times ULN);

You may not qualify if:

• Patient who meet any of the following conditions well excluded in this trial:
• 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;
• Those who meet any of the following conditions during screening:
• positive for hepatitis B surface antigen (HBsAg) and / or hepatitis B e antigen (HBeAg);
• hepatitis B e antibody (HBE AB) and / or hepatitis B core antibody (HBC AB) are positive, and the copy number of HBV-DNA is greater than the lower measurable limit;
• positive for hepatitis C antibody (HCV AB);
• positive anti Treponema pallidum antibody (TP AB);
• HIV antibody test positive;
• the copy number of EBV-DNA and cmv-dna is greater than the lower measurable limit;
• The heart meets any of the following conditions during screening:
• left ventricular ejection fraction (LVEF) ≤ 50% (echo);
• New York Heart Association (NYHA) class III or IV congestive heart failure;
• hypertension (systolic blood pressure ≥ 140mmHg and / or diastolic blood pressure ≥ 90mmHg) or pulmonary hypertension that has not been controlled by standard treatment;

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Interventions

Immune Checkpoint Inhibitors; Antineoplastic Agents

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Therapeutic Uses

Study Officials

• Xiubao Ren, M.D, Ph.D

  ianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liang Liu, M.D

CONTACT

86-22-23340123; liuliang@tjmuch.com

Xiubao Ren, M.D, Ph.D

CONTACT

86-22-23340123; renxiubao@tjmuch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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). 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).

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: November 25, 2024
• Study Start: July 4, 2024
• Primary Completion (Estimated): July 16, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: November 25, 2024

Record last verified: 2024-07

Locations

CN (1)