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Anlotinib with Doxorubicin and Radiotherapy in Neoadjuvant Soft Tissue Sarcoma
NCT06506838Phase 4
Key facts
- Status
- Recruiting
- Start
- Aug 2024
- Primary completion
- Jul 2027
- Countries
- 1
- Sponsor
- Guangdong Provincial People's Hospital
- Modality
- Small Molecules
- Drugs
- anlotinib
- Conditions
- soft tissue sarcoma (STS)
01
Overview
Phase 4, open-label, single-arm trial of anlotinib in soft tissue sarcoma (STS), sponsored by Guangdong Provincial People's Hospital. Primary endpoints: Major Pathological Response rate at 3 months and Pathologic Complete Response rate at 3 months. Started Aug 2024; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Intervention Group
Anlotinib + Doxorubicin + Radiotherapy (Neoadjuvant) -> Surgery -> Doxorubicin (Adjuvant)
03
Who it enrols
Adult patients (18-75) with histologically confirmed high-grade soft tissue sarcoma suitable for resection and radiotherapy, ECOG 0-1, and adequate organ function. Excludes prior anti-tumor therapy within 4 weeks, unresectable tumors, and severe cardiac conditions.
04
Endpoints
Primary
Major Pathological Response rate
Pathologic Complete Response rate
Secondary
Objective Response Rate
Disease-Free Survival
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