NCT05007613

Second-line Cabozantinib and Atezolizumab in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

A Single-arm Phase II Study of Cabozantinib and Atezolizumab in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma Who Failed a Platinum-based Chemotherapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate that combination of cabozantinib and atezolizumab is safe and efficacious in patients with recurrent/metastatic esophageal squamous cell carcinoma.

Detailed description

Patients with histologically proven squamous cell carcinoma of esophagus and had progression from first-line platinum-based chemotherapy for recurrent or metastatic ESCC, or progression within 6 months after neoadjuvant, definitive, or adjuvant chemo(radio) -therapy for loco-regional ESCC would be eligible for this trial. Eligible patients will receive daily 40mg cabozantinib plus i.v. atezolizumab 1200mg Q3W for treatment response evaluation. Primary endpoint is the objective response rate, and secondary endpoints include progression-free survival, overall survival, and safety profiles.

Conditions

• Esophageal Cancer
• Metastatic Cancer
• Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Cabozantinib 40 MG	Cabozantinib (Cabometyx) 40 MG PO QD
DRUG	Atezolizumab Injection	atezolizumab (Tecentriq) 1200mg IVF 30-60mins Q3W

Timeline

• Start date: 2021-06-23
• Primary completion: 2024-07-17
• Completion: 2024-12-01
• First posted: 2021-08-16
• Last updated: 2025-01-01

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated drug study