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Hetrombopag for CCIT in Advanced Solid Tumors
NCT06433830Phase 2
Key facts
- Status
- Recruiting
- Start
- May 2022
- Primary completion
- May 2025
- Countries
- 1
- Sponsor
- Sir Run-Run Shaw Hospital
- Modality
- Small Molecules
- Drugs
- hetrombopag
- Conditions
- Thrombocytopenia
01
Overview
Phase 2, open-label, single-arm trial of hetrombopag in Thrombocytopenia, sponsored by Sir Run-Run Shaw Hospital. Primary endpoint: Proportion of patients with PLT ≥100×10^9/L at 6 weeks. Started May 2022; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Hetrombopag
Patients receive oral hetrombopag at an initial dose of 7.5 mg QD.
03
Who it enrols
Patients with advanced solid tumors experiencing thrombocytopenia (PLT ≤ 75 × 10^9/L) during concurrent chemoradiotherapy.
04
Endpoints
Primary
Proportion of patients with PLT ≥100×10^9/L
Secondary
Median time of PLT ≥100×10^9/L
Incidence of delayed radiotherapy cycles due to thrombocytopenia
Number and percentage of patients receiving platelets transfusion
Incidence of serious adverse events
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