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Anlotinib Combined with Chemoradiotherapy for Refractory and Locally Advanced Head and Neck Cancer
NCT04507035Phase 4
Key facts
- Status
- Unknown
- Start
- Sep 2020
- Primary completion
- Dec 2022
- Countries
- 1
- Sponsor
- Sun Yat-sen University
- Modality
- Small Molecules
- Drugs
- anlotinib
- Conditions
- head and neck cancer (HNC)
01
Overview
Phase 4, open-label, single-arm trial of anlotinib in head and neck cancer (HNC), sponsored by Sun Yat-sen University. Primary endpoints: Objective Response Rate at 3 months and Adverse Events Rate at 3 months. Status: unknown.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Anlotinib group
Anlotinib induction followed by surgery or concurrent chemoradiotherapy + Anlotinib
03
Who it enrols
Patients aged 18-75 with refractory or locally advanced head and neck cancer (squamous or non-squamous), PS 0-1, measurable lesions, and adequate organ function. Excludes patients with prior anti-tumor therapy, uncontrolled hypertension, significant bleeding risk, or recent major surgery.
04
Endpoints
Primary
Objective Response Rate
Adverse Events Rate
Secondary
Progression-Free Survival
Overall Survival
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