Investigating serum ferritin as a biomarker for immune-related adverse events

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

This study is testing if a blood marker called serum ferritin can help doctors identify and predict immune-related side effects in patients with cancer receiving different types of treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1500 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Tianjin Medical University Cancer Institute and Hospital (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT06702566 on ClinicalTrials.gov

What this trial studies

This clinical study aims to evaluate serum ferritin as a potential biomarker for diagnosing, differentiating, and predicting the prognosis of immune-related adverse events (irAE) in patients with malignant solid tumors or acute leukemia. A total of 1500 patients will be enrolled and categorized into three groups based on their anti-tumor therapy: immunotherapy, targeted therapy, or chemotherapy. Blood tests and imaging will be conducted at baseline, with ongoing monitoring of adverse events by a multi-disciplinary team. Patients experiencing adverse events will undergo hematologic testing every three days until recovery, while those without adverse events will have their blood biochemistry re-evaluated every four treatment cycles.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-75 with a definitive diagnosis of malignant solid tumors or acute leukemia who are receiving immunotherapy, targeted therapy, or chemotherapy.

Not a fit: Patients who do not have a malignant solid tumor or acute leukemia, or those outside the age range of 18-75, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the diagnosis and management of immune-related adverse events, leading to improved patient outcomes.

How similar studies have performed: While the approach of using serum ferritin as a biomarker is being explored, this specific application in the context of immune-related adverse events is relatively novel.

Eligibility criteria

Inclusion Criteria:

Only patient who meet all the following conditions can be selected for this trial:

1. Patients voluntarily sign informed consent;
2. The age was 18-75 years old, and the gender was not limited;
3. Patients with definitive diagnosis of malignant solid tumor or acute leukemia;
4. 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.
5. The Eastern Cooperative Oncology Group (ECOG) scored 0 or 1 or 2 for physical fitness;
6. 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;
7. 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);
   * Serum creatinine (SCR) ≤ 1.5 times ULN, or creatinine clearance rate ≥ 60ml / min;
   * Have the lowest level of lung reserve, defined as ≤ grade 1 dyspnea and oxygen saturation \> 91% in non oxygen breathing state;
   * International normalized ratio (INR) ≤ 1.5 times ULN, and activated partial prothrombin time (APTT) ≤ 1.5 times ULN;
8. The urine pregnancy test of women of childbearing age is negative. Any male and female patient with fertility must agree to use effective contraceptive methods during the whole study and at least 1 year after the study treatment.

Exclusion Criteria:

Patient who meet any of the following conditions well excluded in this trial:

1. Active systemic autoimmune disease is known before screening and is under treatment;
2. Those who stopped systemic hormone therapy for less than 2 weeks before enrollment；
3. Those who have received organ / tissue transplantation before screening;
4. 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;
5. 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;
   * have had myocardial infarction or cardiac surgery within 12 months before cell transfusion;
   * clinically significant valvular disease.
6. There are clinical emergencies (such as intestinal obstruction or vascular compression) requiring urgent treatment due to tumor body obstruction or compression during screening;
7. Patients with active bleeding during screening;
8. Patients with deep venous thrombosis or pulmonary embolism within 6 months before screening;
9. Those who received live vaccine within 6 weeks before screening;
10. Patients with active infection and need treatment during screening;
11. Poor compliance.

Where this trial is running

Tianjin, Tianjin Municipality

• Tianjin Medical University Cancer Institute and Hospital — Tianjin, Tianjin Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Xiubao Ren, M.D, Ph.D — ianjin Medical University Cancer Institute and Hospital
• Study coordinator: Liang Liu, M.D

Conditions: Immune-related Adverse Event, Malignant Solid Tumors, Acute Leukemia, Serum Ferritin