MASCT-I Combined With Doxorubicin and Ifosfamide for First-line Treatment of Advanced Soft Tissue Sarcoma

Exclusion Criteria

• •1. Previous treatment with targeted therapy, radiotherapy (radiotherapy to non-target lesions or disease progressed after radiotherapy could be included.) or other antineoplastic drugs such as anlotinib, gemcitabine, within 4 weeks before randomization, or have received Chinese medicine or proprietary Chinese medicine for anti-tumor treatment within 2 weeks before randomization.
• •2. Highly differentiated liposarcoma, malignant perivascular epithelioid tumor, protuberant cutaneous fibrosarcoma, extraosseous osteosarcoma, solitary fibroma/hemangiopericytoma, acinous soft tissue sarcoma, extraosseous myxoid chondrosarcoma, gastrointestinal stromal tumor, invasive fibroma, renal angiomyolipoma, malignant mesothelioma, clear cell sarcoma, Ewing's sarcoma, etc., which are not suitable for Doxorubicin+ Ifosfamide (AI) treatment.
• •3. Previous treatment with anthracyclines or anthraquinones and whose cumulative dose exceeds equivalent 200mg/m2 doxorubicin.
• •4. Previous treatment with MASCT, or have received other cellular immunotherapy or anti-PD-1, anti-PD-L1 antibody therapy in the past 1 year.
• •5. Use of immunosuppressive agents or systemic or inhaled local hormones (exceeding 10mg/day prednisone or its equivalent) and were still using them within 2 weeks before randomization.
• •6. Use of immunomodulators and were still using them within 2 weeks before randomization.
• •7. Allergic to sodium citrate or human albumin.
• •8. Subjects with uncontrolled pleural effusion and abdominal effusion requiring repeated drainage and with moderate or higher volume of pericardial effusion.
• •9. Have known active central nervous system (CNS) or meningeal metastases. Subjects with previously treated brain metastases may participate provided they are stable based on the following: 1) any neurologic symptoms have returned to baseline at least 2 weeks before randomization, 2) no requirement for steroids at least 2 weeks before randomization or receiving low-dose of steroids (Not exceeding 10mg/day prednisone or its equivalent).
• •10. Have any active autoimmune disease or history of autoimmune disease.
• •11. Subjects with active tuberculosis.
• •12. Subjects were infected with hepatitis B virus, hepatitis C virus or HIV, or syphilis.
• •13. Severe cardiovascular disease, such as: (1) complete left bundle branch block or III atrioventricular block; (2) history of myocardial infarction, angioplasty, coronary artery bypass graft; (3) prolonged QT/QTc interval at baseline (male\>450ms, female \>480ms); (4) LVEF≤50%; (5) heart failure of NYHA class 2 or higher; (6) poorly controlled hypertension (BP≥150/95 mmHg, despite optimal medical treatment); (7) cardiomyopathy or severe arrhythmia and may have impact on the study based on investigator's judgement.
• •14. Subjects with history of thrombus or experienced a cerebrovascular accident within 6 months before randomization;
• •15. Other malignant tumors (except cured skin basal cell carcinoma, prostate carcinoma in situ and cervical carcinoma in situ) in the past 5 years;
• •16. Known history of organ transplantation or ready to receive an organ transplantation;
• •17. Subjects who have undergone major surgery or traumatic injury within 4 weeks before randomization;
• •18. Those who have a history of alcohol dependence, psychotropic substance abuse and cannot abstain or have mental disorders.
• •19. Surgery for soft tissue sarcoma is planned during the study.
• •20. Subjects have participated in another investigational trial within 4 weeks before randomization.
• •21. Any condition that the investigator considers to be prejudicial to the subject or to the subject's inability to meet or perform the study requirements exists.