Osteosarcoma
Conditions
Brief summary
This phase II study was designed to assess the efficacy and safety of the combination of Apatinib, Tucidinostat (chidamide), a histone deacetylase inhibitor in relapsed or refractory osteosarcoma patients.
Interventions
DRUGTucidinostat, Apatinib
Tucidinostat: age≥18years, 30mg, po., biw, q4w; age≥10years，\<18years，0.5mg/kg, biw, q4w Apatinib: BSA≥1.2m\^2, 500mg, qd, q4w BSA\<1.2m\^2, 250mg, qd, q4w
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥10 years, ≤ 75 years; 2. Histologically confirmed Advanced classic osteosarcoma with unresectable recurrence or metastatic disease ； 3. Prior treatment consisted of standard chemotherapy agents including doxorubicin, cisplatin, methotrexate, and ifosfamide; 4. Eastern Collaborative Oncology Group (ECOG) 0\ 2； 5. Tumor size is measurable according to RECIST1.1 criteria； 6. Adequate organ function； 7. Life expectancy is more than 3 months； 8. Willing and able to provide written informed consent.
Exclusion criteria
1. Previously exposed to histone deacetylase inhibitors or angiogenesis inhibitors; 2. Urine protein≥ ++; 3. FBG\>10mmol/L; 4. Uncontrolled blodd pressure (ystolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 90 mmHg); 5. Known active CNS metastases and/or carcinomatous meningitis; 6. Not able to take medicine orally; 7. Coagulant function abnormality (PT\>16s, APTT\> 43s, TT\>21s, FIB）\<2g/L); 8. Uncontrolled clinically significant systemic diseases, including active infection, unstable angina, angina occurred within 3 months,≥ NYHA II congestive heart failure, myocardial infarction occurred within 6 months, severe arrhythmia, liver, kidney, or metabolic disease; 9. Major surgery received or severe traumatic injury, fracture, or ulcer occurred within 4 weeks of the first dose of study medication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-month progression-free survival rate | 6 months | The proportion of patients who did not experience disease progression or die from disease progression within 6 months from the treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival(PFS) | 2 years | Time from treatment until disease progression or death |
| Objective Response Rate（ORR） | 2 years | Objective Response Rate（ORR）by RECIST 1.1,the total proportion of patients with complete response（CR）, partial response（PR） |
| Disease Control Rate （DCR） | 2 years | the total proportion of patients with complete response（CR）, partial response（PR）and stable disease（SD） |
| Overall survival(OS) | 2 years | Time from treatment until death from any cause |
Outcome results
None listed