osteosarcoma
Conditions
Interventions
A:Everolimus 5mg qd + Anlotinib 8mg-12mg day 1-21,28-day cycle
B:Camrelizumab 3mg/kg + Ipilimumab 1 mg/kg, 21-days cycle
C:Palbociclib 125mg day 1-21 + gemcitabine 600mg/m2 day 1,8,15,22, 28-days cycle
D:Olaparib 300mg bid day 1-14 + gemcitabine 600mg/m2 day 1,8,15,22, 28-days cycle
D:Metformin 2000mg qd + gemcitabine 675mg/m2 day 1,8, docetaxol 900mg/m2 day 8, 21-days cycle
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
8 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Minors aged between 8 and 70 shall be signed the power of attorney and informed documents by their legal guardian. 2. Primary osteosarcoma was histologically confirmed. 3. Patients with locally advanced, recurrent or metastatic bone and meat cancers cannot be treated with radical surgery. 4. Refractory osteosarcoma (all existing treatments have failed). Specific definition: Currently commonly used chemotherapy drugs in China include methotrexate, ifosfamide, doxorubicin and cisplatin.All of the usual chemotherapy drugs had failed.The patient's condition was not effectively controlled or progressed after admission. 5. At least 1 measurable lesion according to RECIST version 1.1 (conventional CT scan >= 20mm, helical CT scan >= 10mm, measurable lesion not receiving radiotherapy). 6. Subjects voluntarily participate in the study, sign the informed consent, have good compliance, and cooperate with the follow-up. 7. The main organ functions are basically normal and meet the following conditions: 1) Blood routine examination criteria :HB >= 90g/L(no blood transfusion within 14 days), ANC >= 1.5 x 10^9 / L, PLT >= 75 x 10^9 / L. 2) Biochemical examination should be performed according to the following criteria: TBIL <= 1.5 x ULN (the upper limit of normal, ULN, upper limit of normal), ALT and AST <= 3 x ULN, ALT and AST <= 5 x ULN, serum Cr <= 1 x ULN, creatinine clearance rate greater than 50 mL /min (Cockcroft-Gault formula) for liver metastasis. 3) No molecular targeted therapy or surgical treatment was received within 3 weeks before the start of the study, and the acute toxicity of previous treatment has been cured (the wound has fully healed after surgery). 4) During the study period and at least 3 months after the last use of the study drug, fertile female subjects will be required to use medically approved contraceptive drugs.
Exclusion criteria
Exclusion criteria: One of the following situations occurs: 1) Chemotherapy and immunotherapy were performed 3 weeks before treatment. 2) Active systemic infection requiring intravenous antibiotics, clotting dysfunction or cardiovascular disease, active hepatitis, respiratory or immune system other major medical conditions; 3) Elderly patients with poor cardiopulmonary function.Electrocardiogram indicated myocardial ischemia;Left ventricular ejection fraction ;Creatinine clearance rate is 1.5 times of the normal value; 5) Patients with known severe immune dysfunction, or those requiring long-term use of glucocorticoids and immunosuppressive agents; 6) The Common Toxicity Criteria for Adverse Events (CTCAE V 4.03) associated with previous treatment is higher than grade 2, except for peripheral neuropathy, desorption or vitiligo before inclusion. 7) Those suffering from serious neurological, mental and endocrine diseases;Any other conditions identified by the researchers significantly increased the risk of participation. 6.3 Special exclusion criteria for each treatment arm Treatment arm A: Special exclusion criteria for LVEF >= 50% (echocardiography);Has the following heart diseases: (1) angina, (2) arrhythmias requiring treatment or of clinical significance, (3) myocardial infarction, (4) heart failure, and (5) heart diseases that other researchers consider inappropriate for this study. Treatment arm B: For immunotherapy subtypes, the interference of immune factors should be strictly excluded.Subjects should have no history of high dose hormone and other immunosuppressive agents 2 weeks before taking the study drug.In the absence of active autoimmune disease, inhaled or topical use of steroids and adrenocorticosteroid substitutes should be administered within a range of doses.Have a history of active autoimmune diseases, such as interstitial pneumonia, colitis, hepatitis, nephritis, hyperthyroidism, etc.A history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency disorders, or a history of organ transplantation and allogeneic bone marrow transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective mitigation rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control rate (DCR);Progression-free survival (PFS);Overall survival rate (OS); | — |
Countries
China
Contacts
Public ContactZhengdong Cai
Outcome results
None listed