Soft tissue sarcoma and osteosarcoma
Conditions
Interventions
Experimental group:sintilimab in combination with anlotinib
Sponsors
Shandong First Medical University Affiliated Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years; 2. Pathologically diagnosed as soft tissue sarcoma or osteosarcoma with measurable lesions (meeting RECIST 1.1 criteria); 3. Patients with distant metastasis or inoperable complete resection based on imaging findings after assessment of disease progression after first-line standard chemotherapy; 4. First- and second-line treatment of acinar soft tissue sarcoma, extraskeletal mucinous chondrosarcoma, well-differentiated/dedifferentiated liposarcoma, clear cell sarcoma, inflammatory myofibroblastic tumor and other special types of soft tissue tumors that are not suitable for chemotherapy; 5. Have not received immune and targeted therapy; 6. Any PD-L1 status; patients can receive tumor tissue genetic testing; 7. ECOG PS: 0-1 points; 8. The patient's expected survival period is >=3 months; there are indications for systemic treatment, and there are no contraindications; 9. The patient can understand and sign the informed consent form (when the subject is incapacitated, it will be signed by his legal representative).
Exclusion criteria
Exclusion criteria: 1. The patient has any active autoimmune disease or has a history of autoimmune disease; 2. Active infection requiring systemic treatment; 3. There are clinical symptoms or diseases of the heart that are not well controlled, such as: (1) Heart failure of NYHA grade 2 or above; (2) Unstable angina; (3) Myocardial infarction occurred within 1 year; (4) Clinically significant supraventricular or ventricular arrhythmias require treatment or intervention; (5) QTc > 450ms (male), QTc > 470ms (female); 4. Requires cortisol (>10 mg/day prednisone or equivalent) or other systemic immunosuppressive drugs (except inhaled or topical corticosteroids) within 14 days prior to study treatment or prednisone at doses greater than 10 mg/day or equivalent in replacement therapy; 5. Patients with past and current objective evidence of interstitial lung disease; 6. Previously received PD-1, PD-L1, CTLA-4 and other antibodies and anti-angiogenesis targeted therapy; 7. Less than 4 weeks before the study medication or possibly inoculated with live vaccine during the study period; 8. Pregnant or lactating patients; 9. Known history of human immunodeficiency virus (HIV); 10. Known active hepatitis B or C; 11. Patients with known mental illness or substance use disorder; 12. According to the judgment of the researcher, the patients have other factors that may cause the study to be terminated halfway. If there is a serious abnormal laboratory test, accompanied by family or social factors, it will affect the safety of the patients, or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival; Progression Free Survival;Adverse Reactions;Quality of Life Score; | — |
Countries
China
Contacts
Public ContactZhu Dongyuan
Shandong First Medical University Affiliated Cancer Hospital
Outcome results
None listed