soft tissue sarcoma
Conditions
Interventions
Soft tissue sarcoma group:zimberelimab administered in combination with anlotinib and eribulin
Sponsors
SanHuan Cancer Hospital, Chaoyang District, Beijing
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participated in clinical research and signed informed consent form; 2. Age =18 years and =70 years; 3. Histologically or cytologically confirmed advanced or unresectable soft tissue sarcomas, including but not limited to: undifferentiated sarcoma, liposarcoma, leiomyosarcoma, synovial sarcoma, fibrosarcoma, angiosarcoma; 4. No previous systemic therapy was performed; 5. The PD-L1 test report of tumor tissue samples (paraffin specimens or fresh tumor tissues within 2 years) or tumor tissue samples issued by qualified units approved by the state can be provided; 6. ECOG score 0-1; 7. Expected survival period = 3 months; 8. At least one measurable lesion (according to RECIST v1.1); 9. Patients must be able to swallow oral medications and have no significant gastrointestinal abnormalities involved; 10. Adequate function of major organs is defined as: ? Blood routine (no blood transfusion, albumin, recombinant human thrombopoietin or colony stimulating factor treatment within 14 days before examination): white blood cell (WBC) = 4.0 × 10^9/l, absolute neutrophil count (ANC) = 1.5 × 10^9/l, platelet count (PLT) = 100 × 10^9/l, hemoglobin (HB) = 90g/l (no blood transfusion and blood products within 14 days, no hematopoietic stimulating factor correction); ? Liver function: total bilirubin (TBIL) = 2.5 × ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3 × ULN, serum albumin = 3.0g/dl (30 g/l); ? Renal function: creatinine clearance rate (CCR) = 60ml/min (Cockcroft Gault formula); ? Coagulation function: international normalized ratio (INR) or prothrombin time (PT) = 1.5 × ULN; 11. According to the investigator's assessment, the heart and lung functions were normal; 12. The blood pressure is normal, and the blood pressure of patients with hypertension is well controlled (not higher than 140 / 90 mmHg); 13. No obvious contraindications to chemotherapy, anti angiogenic therapy and immunotherapy; 14. Voluntarily take effective contraceptive measures during the study treatment period and within 120 days after the end of treatment; 15. Women of childbearing age must have taken reliable contraceptive measures, and blood pregnancy test must be carried out within 7 days before enrollment, and the result is negative.
Exclusion criteria
Exclusion criteria: 1. The primary lesion is not clear; 2. Had received radiotherapy (or other non systemic treatment) within the first 2 weeks before enrollment or did not fully recover from adverse events due to previously received treatment; 3. Previously received anti-PD-1/PD-L1 antibody, anti-PD-L2 antibody, CTLA-4 antibody, or other drugs /antibodies acting on T cell costimulation or checkpoint pathway; 4. Patients with severe active autoimmune disease who need to receive glucocorticoid or systemic immunosuppressive therapy within 2 years before the first administration. Patients whose diseases have been controlled and do not need systemic immunosuppressive therapy are allowed to be enrolled, such as type I diabetes mellitus, hypothyroidism that only needs hormone replacement therapy, and skin diseases that do not need systemic treatment (such as vitiligo, psoriasis, and alopecia); 5. Patients with congenital or acquired immune deficiency (such as HIV infection), active hepatitis B (HBV-DNA = 1×10^4 copy number /ml or 2000 IU/ml) or hepatitis C (hepatitis C antibody is positive and HCV-RNA is higher than the detection limit of the analytical method); 6. There is infectious disease within 14 days before the first administration, and systemic anti infection treatment is required; 7. Subjects who need to use corticosteroids (>10 mg/ day prednisone or equivalent dose of similar drugs) or other immunosuppressants for systemic treatment within 14 days before or during the first administration of study drugs. In the absence of active autoimmune disease, inhaled or topical steroids, or adrenal hormone replacement at a dose = 10 mg/ day of prednisone efficacy dose, are allowed; 8. Have used Chinese herbal medicine or traditional Chinese medicine preparation with anti-tumor indications within 14 days before the first administration (subject to the instructions); 9. Known history of specific substance abuse (such as psychotropic drugs, alcohol abuse, etc.) or drug abuse; 10. Cardiovascular and cerebrovascular diseases (myocardial infarction, severe / unstable angina, NYHA grade 2 or above cardiac dysfunction and symptomatic congestive heart failure, cerebrovascular accidents such as stroke) or poorly controlled arrhythmias (including QTc interval > 480ms, QTc interval calculated by fridericia formula) within 6 months before the first administration; 11. The investigator assessed that he had undergone major surgery and had not recovered within 28 days before the first dose; 12. Have a history of major vascular disease or hemorrhagic disease within 6 months before the first administration (for example, aortic aneurysm requiring surgical repair or recent peripheral artery thrombosis, portal hypertension with gastrointestinal bleeding, etc.); 13. Any other malignant tumor diagnosed within 3 years before entering the study, except skin basal cell carcinoma or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, breast ductal carcinoma in situ and papillary thyroid cancer that can be treated locally and have been cured; 14. Previous or planned organ transplantation (including bone marrow transplantation); 15. Have been vaccinated with live vaccine within 4 weeks before the first use of study drug (inactivated vaccine is allowed); 16. Participated in other clinical trials within 4 weeks before enrollment; 17. Known allergy to the study drug or any of its excipients, or severe allergic reaction to other monoclonal antibodies. 18. Pregnant or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free-Survival, PFS;Overall Survival, OS;Disease Control Rate, DCR;safety; | — |
Countries
China
Contacts
Public ContactSang Die/ Yuan Peng
SanHuan Cancer Hospital, Chaoyang District, Beijing
Outcome results
None listed