Clinical trial · Interventional
Tucidinostat Plus Apatinib for Advanced Osteosarcoma
A Phase II Clinical Trial of Tucidinostat in Combination With Apatinib in Patients With Relapsed or Refractory Osteosarcoma
NCT06125171CI-TRIAL-00071230unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tucidinostat, Apatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tucidinostat+Apatinib
- interventionNames
- Drug: Tucidinostat, Apatinib
Primary outcomes (1)
- measure
- 6-month progression-free survival rate
- timeFrame
- 6 months
- description
- The proportion of patients who did not experience disease progression or die from disease progression within 6 months from the treatment
Secondary outcomes (4)
- measure
- Progression-free survival(PFS)
- timeFrame
- 2 years
- description
- Time from treatment until disease progression or death
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.