APX005M With Concurrent Chemoradiation for Resectable Esophageal and Gastroesophageal Junction Cancers
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 16
Summary
- Conditions
- Esophageal Cancer
- Gastroesophageal Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Non-comparative, open-label pilot studyMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To establish the safety and feasibility of combining APX005M with standard-of-care chemoradiation (external beam radiation in daily fractions, with concurrent weekly low-dose carboplatin/paclitaxel) in the neoadjuvant setting for patients with resectable esophageal and gastroe...
PRIMARY OBJECTIVES: I. To establish the safety and feasibility of combining APX005M with standard-of-care chemoradiation (external beam radiation in daily fractions, with concurrent weekly low-dose carboplatin/paclitaxel) in the neoadjuvant setting for patients with resectable esophageal and gastroesophageal junction (GEJ) cancers. SECONDARY OBJECTIVES: I. To assess the efficacy of this novel combination, as measured by the pathologic complete response (pCR) rate. OUTLINE: Patients receive APX005M intravenously (IV) over 60 minutes during weeks 1, 4, and 7, radiation therapy once daily (QD) for 5 days per week during weeks 3-8, and paclitaxel IV over 60 minutes and carboplatin IV over 60 minutes once weekly (days 1, 8, 15, 22, and 29) during weeks 3-8 in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery 4 - 10 weeks after last dose of APX005M. After completion of study treatment, patients are followed up at 1, 3, and 6 months.
Tracking Information
- NCT #
- NCT03165994
- Collaborators
- Not Provided
- Investigators
- Study Director: Ovid Trifan, MD CMO
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