Study on the Correlation Between Immunoglobulin and Liposomal Doxorubicin in Vivo

  • STATUS
    Recruiting
  • End date
    Nov 1, 2022
  • participants needed
    30
  • sponsor
    Fudan University
Updated on 12 May 2022

Summary

To study the correlation between the content of natural IgM in patients' blood samples and liposomal doxorubicin for clinical use, and to explore the possibility of using natural IgM content to guide clinical accurate medication.

Details
Condition Advanced Malignant Tumors
Treatment doxorubicin hydrochloride liposome injection
Clinical Study IdentifierNCT05354076
SponsorFudan University
Last Modified on12 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients aged 18-70 years (including cutoff value), regardless of gender
According to the clinical diagnosis and treatment norms, it is suitable for patients with advanced malignant tumors diagnosed by histopathology with doxorubicin hydrochloride liposome injection chemotherapy
Eastern Cooperative Oncology Group Performance Status of 0-1
Life expectancy ≥ 3 months
Adequate function of major organs meets the following requirements
Neutrophils ≥ 1.5×10^9/L
Platelets ≥ 75×10^9/L
Hemoglobin ≥ 90g/L
Total bilirubin≤ 1.5 × the upper limit of normal (ULN)
ALT and AST ≤ 2.5 × ULN, Subjects with liver metastasis require TBIL ≤ 1.5 × ULN, ALT and AST ≤ 5 × ULN。
BUN and Cr ≤ 1.5 × ULN, Or creatinine clearance (CCR) ≥ 50 ml / min
International normalized ratio(INR)≤1.5 × ULN,activated partial thromboplastin time(APTT) ≤ 1.5 × ULN
Women should agree to use effective contraceptives (such as intrauterine device [IUD]
contraceptive or condom) during the study period and within 6 months after the
end of the study; serum pregnancy test is negative within 7 days before the
study and must be non lactating subjects; men should be the same subjects who
intend to use contraceptives during the study period and within 6 months after
the end of the study period
Patients volunteered to participate in the study, signed informed consent, and were able to follow the blood sampling, visit and related procedures specified in the trial

Exclusion Criteria

Received systemic therapy such as chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy and other anti-tumor treatments within 4 weeks before enrollment; according to the judgment of the researcher, the cleaning period can be appropriately shortened or extended. For example, for endocrine drugs, in order to avoid making patients wait too long, the cleaning period can be appropriately shortened to 2 weeks
Those weighing less than 40 kg
Previously received any liposomal doxorubicin analogues treatment
Patients with a history of allergy to liposomes or adriamycin
Have a history of serious cardiovascular disease, such as severe cardiac rhythm or conduction abnormalities (ventricular arrhythmia requiring clinical intervention, degree II ~ III atrioventricular block, etc.), cardiac infarction, history of coronary artery bridging surgery, heart failure, NYHA grade II or above, left ventricular ejection fraction (LVEF) ≤ 50%, male QTCF > 450msec or female QTCF > 470msec, etc
Patients with active infection (NCI CTC AE v5.0 ≥ grade 2)
Patients have a history of autoimmune diseases and immune defects, including HIV test positive, or have other acquired and congenital immune defects, or have a history of organ transplantation and need to take corticosteroids routinely
Hepatitis B surface antigen positive (HBsAg), and peripheral blood hepatitis B virus DNA (HBV-DNA) titer detection is more than 1. ×103 IU / ml; If HBsAg is positive and HBV-DNA in peripheral blood is less than 1 × 103IU/mL, if the researchers believe that the chronic hepatitis B is stable and does not increase the risk of the subjects, the subjects are eligible to be selected
Anti hepatitis C virus antibody and anti treponema pallidum specific antibody were positive
Have a clear history of neurological or mental disorders, including epilepsy or dementia
Patients with clinical symptoms of central nervous system metastasis or meningeal metastasis, or other evidence indicating that the patient's central nervous system metastasis or meningeal metastasis has not been controlled, patients with asymptomatic brain metastasis, or stable clinical symptoms without steroid hormone and other treatment for brain metastasis for ≥ 28 days can be enrolled
According to the judgment of the investigator, there are other accompanying diseases that seriously endanger the safety of the patient or affect the completion of the study
Pregnant or lactating female subjects
Patients considered unsuitable by the investigator to participate in this study
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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