Soft tissue sarcoma
Conditions
Interventions
Experimental group:Legubicin
Control group:Doxorubicin hydrochloride
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18~75 years (including the critical value), no gender limit; 2. Subjects with histologically or cytologically confirmed advanced soft tissue sarcomas (i.e. locally advanced or recurrent and/or metastatic soft tissue sarcomas that are inoperable. Alveolar soft tissue sarcoma, clear cell sarcoma, gastrointestinal stromal tumor, vascular endotheliosarcoma, chondrosarcoma, extraosseous Ewing's sarcoma, rhabdomyosarcoma were excluded); 3. Subjects who had not received prior standard chemotherapy, or had received prior first-line treatment with isocyclophosphamide, or had received adjuvant chemotherapy or neoadjuvant chemotherapy and relapsed and/or metastasized with doxorubicin or other anthracyclines more than 6 months between the last chemotherapy were enrolled with doxorubicin dose =10mm, lymph node diameter >=15mm); 5. The ECOG status score of the American Eastern Oncology Consortium (ECOG) was 0-1, and the ECOG status score of subjects with limb tumors was 0-2; 6. Expected survival >=3 months; 7. The level of organ function must meet the following requirements: (1) Hematology (no blood transfusion or hematopoietic stimulating factor treatment within 14 days) : neutrophil absolute value (ANC) >=1.5x10^9/L, platelet count (PLT) >=75x10^9/L, hemoglobin (Hb) >=90 g/L; (2) Liver function: total bilirubin (TBIL) =50 mL/min (calculated according to Cockcroft-Gault formula); (4) Coagulation function: activated partial thromboplastin time (APTT) =55% (measured by biplane Simpson method); 2) NT-proBNP< age limit value; 3) The troponin is within the normal range; (4) 12-lead electrocardiogram: no serious arrhythmia, QTcF <=480ms; 8. Fully understand and know about this study, sign informed consent, voluntarily participate in clinical study and be able to complete all research procedures.
Exclusion criteria
Exclusion criteria: 1. Allergic to test drugs and similar substances or their excipients and known history of alcohol allergy; 2. Patients who have had any other malignant neoplasms in the past 5 years or currently, except those who have been completely cured of basal cell carcinoma, squamous cell carcinoma of the skin, melanoma in situ and carcinoma in situ of the cervix; 3. Previous treatment with any of the following: (1) Have received other antitumor therapy, such as chemotherapy, radiotherapy, surgery, endocrine therapy, targeted therapy, immunotherapy, etc., within 4 weeks prior to initial medication or within 5 half-lives (whichever is the older); (2) Received TCM treatment within 2 weeks before the first medication; (3) Received mitomycin C within 6 weeks prior to initial administration; 4. Had major surgery (excluding needle biopsy) or severe trauma within 4 weeks prior to initial medication, or planned to undergo elective surgery during the trial; 5. Received other investigational drugs or participated in other clinical studies within 4 weeks before the first drug use; 6. Prior to the first drug administration, the adverse reactions of previous antitumor therapy had not recovered to =500IU/mL or the lower limit of its reference value; Or HCV infection; The following patients are eligible: (1) Hepatitis B virus core antibody positive and hepatitis B virus surface antigen negative and HBV-deoxyribonucleic acid (DNA) < 500 IU/mL (< 2500 copy/mL if only copy/mL testing unit is available in the study center) 28 days prior to initial administration; If the study center has a different range of normal values and does not meet the positive criteria), has received oral anti-HBV therapy at least 14 days prior to initial administration of the experimental drug (in accordance with local standard treatment, such as Entecavir) and is willing to receive antiviral therapy throughout the study period; (2) Hepatitis C virus (HCV) RNA positive patients must receive antiviral therapy according to standard local treatment guidelines and have liver function recovery within NCI CTCAE v5.0 level 1; 9. Have a history of immunodeficiency, or test positive for HIV antibodies; 10. Vaccines (live and attenuated) such as measles, mumps, rubella, chickenpox, yellow fever, rabies, BCG and typhoid (oral) vaccines have been administered within 4 weeks prior to initial administration. Allowing all types of COVID-19 vaccines; 11. A history of severe cardiovascular and cerebrovascular diseases, including but not limited to: (1) Past myocardial infarction and cerebral hemorrhage; (2) Patients with arteriovenous thrombosis (such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism) that had occurred within 6 months prior to initial administration without formal treatment; (3) Severe cardiovascular and cerebrovascular diseases, such as acute coronary syndrome, congestive heart failure (New York Heart Association Heart function Scale ?-?), ischemic stroke (excluding lacunar infarction), aortic dissection, etc., occurred within 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival ; | — |
Countries
China
Contacts
Public ContactShen Zan
Shanghai Sixth People's Hospital
Outcome results
None listed