Soft tissue sarcoma
Conditions
Interventions
Experimental group:Anlotinib + Toripalimab
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Unresectable locally advanced or metastatic STS; 2. Aged >= 18 years; 3. Stable disease (SD) or complete/partial response(CR/PR)after first-line anthracycline-based chemotherapy; 4. At least 1 measurable lesions according to CT or MRI; 5. Eastern Cooperative Oncology Group (ECOG) performance status score 0-1; 6. Neutrophils (ANC) >= 1500/uL, platelet count (PLT) >= 100000/uL and hemoglobin (Hb)>= 9.0 g/dL; 7. International normalized ratio (INR) <= 1.5 x ULN; 8. Serum creatinine (Cr) <= 1.5 x ULN; 9. ALT and AST <= 2.5 x ULN(if accompanied by liver metastases, ALT and AST <= 5 x ULN)and bilirubin <= 1.5 x ULN.
Exclusion criteria
Exclusion criteria: 1. Suffer from any other malignancy at the time of enrollment; 2. Histologically confirmed gastrointestinal stromal tumor, embryonic or alveolar rhabdomyosarcoma, dermatofibrosarcoma protuberans, extraosseous Ewing's sarcoma/primordial neuroectodermal tumor, ALK-positive inflammatory myofibroblasts, clear cell sarcoma, glands Alveolar soft tissue sarcoma, malignant mesothelioma, etc.; 3. Patients with any autoimmune disease; 4. With active brain metastases; 5. Evidence of active infections; 6. Any bleeding episodes within 4 weeks prior to enrollment; 7. LVEF < 55%.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-week PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Median PFS (Progress-Free Survival);Median OS (Overall Survival);Safety; | — |
Countries
China
Contacts
Public ContactJiang Yu
West China Hospital, Sichuan University
Outcome results
None listed