Advanced Osteosarcoma and Soft Tissue Sarcoma
Conditions
Interventions
A:MASCT-I A+PD1 antibody+Apatinib
B:MASCT-I B+PD1 antibody+Apatinib
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
14 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 14-70 years old; 2. Obtain the written informed consent of the patient/legal representative; 3. In patients with unresectable recurrence or metastasis of advanced bone and soft tissue sarcoma, histological or cytological evidence shows that objective imaging progress (RECIST 1.1) occurs after first-line or multi-line treatment, and the maximum diameter of metastatic lesions = 6 months; 7. At least 4 weeks after the end of the last chemotherapy; 8. Cardiopulmonary function is basically normal; 9. Tumor tissue specimens (for PDL1, MSI detection) can be provided; 10. Blood samples can be provided (for the detection of immune response); 11. The function of important organs meets the following requirements (no blood components and growth factors are allowed to be used within 14 days before screening); (1) Hemoglobin >=90g/L; (2) Leukocyte >=3.0 *10^9/L; (3) The absolute neutrophil count (ANC) >=1.5x10^9/L; (4) Platelet >=70 *10^9/L; (5) ALT, AST =30g/L.
Exclusion criteria
Exclusion criteria: 1. Those with bone or brain metastases; 2. Subjects were using immunosuppressive agents or systemic or absorbable local hormones to achieve immunosuppressive 3. purposes (dose > 10mg/prednisone or other therapeutic hormones) and were still using them within 2 weeks before admission.Systematic or long-term use of immunomodulators such as interferon, thymosin and immunosuppressive drugs such as adrenocorticosteroids in half a year; Systematic or long-term use of immunomodulators for more than three months and immunosuppressive drugs for more than one month; 4. The subjects had received radiotherapy in the past one year; 5. The subjects had received MASCT or other cellular immunotherapy or PD1/PDL1/CTLA-4 antibody therapy in the past 1 year; 6. Subjects had any active autoimmune disease or history of autoimmune disease; 7. The subjects had active tuberculosis; 8. Subjects were infected with hepatitis B, hepatitis C or HIV, or syphilis; 9. Pregnancy or planned pregnancy; 10. People allergic to sodium citrate or human albumin; 11. Severe coagulation dysfunction (PT, TT, APTT or any of fibrinogen abnormalities and clinical significance); 12. According to the judgement of the researcher, it is not suitable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;DCR;OS; | — |
Countries
China
Contacts
Public ContactYao Yang
Shanghai Sixth People's Hospital
Outcome results
None listed