Status:
UNKNOWN
Tucidinostat Plus Apatinib for Advanced Osteosarcoma
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions:
Osteosarcoma
Eligibility:
All Genders
10-75 years
Phase:
PHASE2
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 pati...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06125171
Start Date
January 1 2024
End Date
December 1 2025
Last Update
November 9 2023
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