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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| liposomal doxorubicin | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| doxorubicin hydrochloride liposome injection | Drug | 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.(For breast cancer patients: liposomal doxorubicin 35mg/m2 q3w) |
| Measure | Description | Time Frame |
|---|---|---|
| The content of natural IgM in patients' blood samples | IgM regulates the performance of liposomes by regulating the efficiency of liposomes activating complement in vivo. Among many immunoglobulins, IgM rather than IgG is the key plasma protein affecting the efficiency of liposomes activating complement.The content of IgM in serum were detected by ELISA | 6 weeks |
| Number of participants with treatment-related adverse events as assessed by NCI CTCAE v5.0 | 6 weeks |
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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 :
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Zhang, MD,PhD | Contact | 021-64175590 | 73546 | syner2000@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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