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Neoadjuvant Nab-paclitaxel, Cisplatin, and Capecitabine for Esophageal Squamous Cell Carcinoma
NCT04390958Phase 2
Key facts
- Status
- Unknown
- Start
- May 2020
- Primary completion
- Jun 2022
- Countries
- 1
- Sponsor
- Chinese Academy of Medical Sciences
- Modality
- Small Molecules
- Drugs
- paclitaxel
- Conditions
- Esophageal Squamous Cell Carcinoma (ESCC)
01
Overview
Phase 2, open-label, single-arm trial of paclitaxel in Esophageal Squamous Cell Carcinoma (ESCC), sponsored by Chinese Academy of Medical Sciences. Primary endpoint: Pathological Complete Response Rate at 2 years. Status: unknown.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Neoadjuvant chemotherapy group
Nab-paclitaxel + Cisplatin + Capecitabine followed by surgery
03
Endpoints
Primary
Pathological Complete Response Rate
Secondary
Objective Response Rate
R0 Resection Rate
Major Pathological Response Rate
Overall Survival
Disease Free Survival
Progression-Free Survival
Recurrence Rate
Treatment-Emergent Adverse Events
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