Tucidinostat Plus Apatinib for Advanced Osteosarcoma

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II Clinical Trial of Tucidinostat in Combination With Apatinib in Patients With Relapsed or Refractory Osteosarcoma

Conditions
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Osteosarcoma

Intervention / Treatment
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* Drug: Tucidinostat, Apatinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥10 years, ≤ 75 years; Histologically confirmed Advanced classic osteosarcoma with unresectable recurrence or metastatic disease ； Prior treatment consisted of standard chemotherapy agents including doxorubicin, cisplatin, methotrexate, and ifosfamide; Eastern Collaborative Oncology Group (ECOG) 0 2； Tumor size is measurable according to RECIST1.1 criteria； Adequate organ function； Life expectancy is more than 3 months； Willing and able to provide written informed consent. Exclusion Criteria: Previously exposed to histone deacetylase inhibitors or angiogenesis inhibitors; Urine protein≥ ++; FBG>10mmol/L; Uncontrolled blodd pressure (ystolic blood pressure > 150 mmHg and/or diastolic blood pressure > 90 mmHg); Known active CNS metastases and/or carcinomatous meningitis; Not able to take medicine orally; Coagulant function abnormality (PT>16s, APTT> 43s, TT>21s, FIB）<2g/L); 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; Major surgery received or severe traumatic injury, fracture, or ulcer occurred within 4 weeks of the first dose of study medication.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tucidinostat+Apatinib<br> | Drug: Tucidinostat, Apatinib<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-month progression-free survival rate | The proportion of patients who did not experience disease progression or die from disease progression within 6 months from the treatment | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival(PFS) | Time from treatment until disease progression or death | 2 years | 
| Objective Response Rate（ORR） | Objective Response Rate（ORR）by RECIST 1.1,the total proportion of patients with complete response（CR）, partial response（PR） | 2 years | 
| Disease Control Rate （DCR） | the total proportion of patients with complete response（CR）, partial response（PR）and stable disease（SD） | 2 years | 
| Overall survival(OS) | Time from treatment until death from any cause | 2 years |