This study will evaluate the safety and efficacy of MASCT-I combined with Doxorubicin and Ifosfamide for first-line treatment in patients with advanced soft tissue sarcoma.
Age≥18 years and≤70 years;
According to WHO Classification of Tumours, 5th Edition, Volume 3: Soft Tissue and Bone Tumours, histopathologically or cytologically confirmed unresectable locally advanced or metastatic soft tissue sarcomas, including leiomyosarcoma, liposarcoma, synovial sarcoma, angiosarcoma, undifferentiated pleomorphic sarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumors, fibrosarcoma, pleomorphic rhabdomyosarcoma, endometrial stromal sarcoma, desmoplastic small round cell tumor.
No previous treatment with systematic chemotherapy or targeted therapy for advanced soft tissue sarcomas or whose disease progressed after 6months of the end of neoadjuvant or adjuvant therapy.
At least one measurable and assessable lesion defined by RECIST 1.1;
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.
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.
Previous treatment with anthracyclines or anthraquinones and whose cumulative dose exceeds equivalent 200mg/m2 doxorubicin.
Previous treatment with MASCT, or have received other cellular immunotherapy or anti-PD-1, anti-PD-L1 antibody therapy in the past 1 year.
Parallel
MASCT-I
Biological/VaccineThe final products of MASCT-I technology are dendritic cells (DC) and effector T cells.
Doxorubicin
DrugCommercially approved for cancer treatment
Ifosfamide
DrugCommercially approved for cancer treatment
Progression-Free Survival (PFS)
The time from the date of randomization to the first occurrence of radiological progression or death, whichever comes first.
Overall Survival (OS)
The time from the date of randomization to the date of death from any cause.
Objective Response Rate (ORR)
The percentage of participants with complete response (CR) or partial response (PR) via investigator assessment per RECIST (Response Evaluation Criteria In Solid Tumors Criteria) v1.1 relative to the total number of participants in the analysis population.
Disease Control Rate (DCR)
The percentage of participants with CR, PR, or stable disease (SD) relative to the total number of participants within the analysis population as determined by Investigators per RECIST v1.1.
Duration of response (DoR)
The time from first documentation of response of PR or better to first documentation of disease progression or death from any cause, whichever comes first.
Immune response to tumor-associated antigens
Measured by enzyme linked immunospot assay
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HRYZ Biotech Co.
Lead sponsor
Sun Yat-Sen University Cancer Center
Collaborator
