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New treatment option for Immune-related Adverse Event
Official title The Effect of Serum Ferritin in irAE
ClinicalTrials.gov ID: NCT06702566
What this study is testing
What is PD-1 and PD-L1 inhibitor?
PD-1 and PD-L1 inhibitor is an investigational medicine, being studied as a potential treatment for immune-related adverse event.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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...
You likely can't join 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);
See the full eligibility criteria
- 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...
- 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);
- 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;
- 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...
- 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;
- have had myocardial infarction or cardiac surgery within 12 months before cell transfusion;
- clinically significant valvular disease.
- There are clinical emergencies (such as intestinal obstruction or vascular compression) requiring urgent treatment due to tumor body obstruction or compression during screening;
- Patients with active bleeding during screening;
- Patients with deep venous thrombosis or pulmonary embolism within 6 months before screening;
- Those who received live vaccine within 6 weeks before screening;
- Patients with active infection and need treatment during screening;
- Poor compliance.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.