Tucidinostat Plus Apatinib for Advanced Osteosarcoma

Sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study ID
NCT06125171
Phase
PHASE2
Status
Unknown

Conditions

  • Osteosarcoma

Eligibility Criteria

Sex
ALL
Age
10 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Tucidinostat, Apatinib — DRUG
    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

Study Details

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.

Key Dates

Start date
Jan 31, 2024
Status verified
Nov 2023
Primary completion
Dec 31, 2024
Completion
Dec 31, 2025

Study Design

Enrollment
46 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tucidinostat+Apatinib

Primary Outcome Measure

6-month progression-free survival rate [ Time Frame: 6 months ]

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