Soft Tissue Sarcoma
Conditions
Interventions
Test group:drug treatment
Sponsors
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Patients must meet all of the following inclusion criteria to be eligible for this trial: 1.Age: 18–70 years, gender (unrestricted); 2.Histopathologically and radiologically diagnosed as unresectable locally advanced or metastatic soft tissue sarcoma, with main types including: leiomyosarcoma, liposarcoma, synovial sarcoma, angiosarcoma, undifferentiated pleomorphic sarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumor, fibrosarcoma, pleomorphic rhabdomyosarcoma, endometrial stromal sarcoma, desmoplastic small round cell tumor. 3.No prior systemic chemotherapy or targeted immunotherapy for advanced soft tissue sarcoma; patients who received neoadjuvant or adjuvant therapy must have disease progression more than 6 months after completion of treatment; 4.According to RECIST 1.1, measurable lesions must be present at baseline; 5.ECOG Performance Status Score (Appendix 2) is 0–1, with an expected survival of more than 3 months; 6.Recovery from previous treatment: Based on NCI-CTCAE 5.0 (Appendix 5), all adverse effects (except alopecia) have resolved to grade 1 or below; 7.Normal major organ function, meeting the following criteria: Hemoglobin (Hb)>= 95 g/L, Absolute Neutrophil Count (ANC) >= 1.5 × 10?/L, Platelet Count (PLT) >= 80 × 10?/L, Serum Creatinine (Cr) = 35 g/L, Prothrombin Time (PT) and Partial Thromboplastin Time (PTT) = 50%, Blood pressure controlled within 140/90 mmHg before enrollment; 8.For women of childbearing potential, reliable contraception must be in place or a pregnancy test (serum or urine) must have been performed within 7 days prior to enrollment, with a negative result. They must also agree to use appropriate contraceptive methods during the study period and for 8 weeks after the last administration of the investigational drug. For males, they must agree to use appropriate contraceptive methods during the study period and for 8 weeks after the last administration of the investigational drug, or have undergone surgical sterilization; 9.Signed informed consent form (or signed by a legal representative), confirming that they understand the purpose of the study and the procedures required by the study, and are willing to participate in the study.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will not be eligible for this study: 1.Exclusion of high-grade liposarcoma, malignant perivascular epithelioid cell tumor, dermatofibrosarcoma protuberans, extraosseous osteosarcoma, solitary fibrous tumor/extramedullary hematopoiesis, alveolar soft part sarcoma, extraosseous myxoid chondrosarcoma, gastrointestinal stromal tumor (GIST), aggressive fibromatosis, renal angiomyolipoma, malignant mesothelioma, clear cell sarcoma, Ewing's sarcoma, and other tumors unsuitable for AI treatment. 2.Patients who have previously received cumulative doses of enzalutamide or similar drugs exceeding the equivalent of doxorubicin 200 mg/m². 3.Presence of any active autoimmune disease or history of autoimmune disease; 4.History of other malignancies within the past 5 years or concurrent malignancy, except for cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the basement membrane)]; 5.Active infection requiring systemic therapy; 6.Uncontrolled cardiac clinical symptoms or diseases, such as: (1) NYHA Class 2 or higher heart failure; (2) unstable angina; (3) myocardial infarction within the past year; (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention; (5) QTc > 450 ms (male); QTc > 470 ms (female); 7.Use of corticosteroids (more than 10 mg/day) or other systemic immunosuppressive drugs (excluding inhaled or topical corticosteroids) or equivalent doses of prednisone (>10 mg/day) within 14 days prior to study treatment; 8.Patients with objective evidence of interstitial lung disease in the past or currently; 9.Vaccination with live vaccines within 4 weeks before study drug administration or possible vaccination during the study period; 10.Pregnant or breastfeeding women; 11.Known history of human immunodeficiency virus (HIV/AIDS); 12.Known active hepatitis B or hepatitis C; 13.Known psychiatric disorders or substance abuse disorders; 14.As judged by the investigator, the subject has other factors that may lead to premature termination of the study, such as severe laboratory abnormalities, family or social factors that may affect the safety of the subject, or collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Progression Free Survival;Disease Control Rate;Adverse Reactions; | — |
Countries
China
Contacts
Public ContactZhu Dongyuan, Zhang Hui
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Outcome results
None listed