NCT03544736

Safety and Feasibility of Irradiation and Nivolumab in Esophageal Cancer (INEC)

Safety and Feasibility of Irradiation and Nivolumab in Esophageal Cancer (INEC-study) - a Phase I/II Trial

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Three parallel cohort, multicenter, open-label, phase I/II clinical trial to analyze the safety and feasibility of PD-1 inhibition with Nivolumab given concomitantly with standard radiotherapy regimens in the treatment of esophageal cancer

Detailed description

Three parallel cohort, multicenter, open-label, phase I/II clinical trial to analyze the safety and feasibility of PD-1 inhibition with Nivolumab given concomitantly with standard radiotherapy regimens in the treatment of esophageal cancer. Cohort A: Advanced/inoperable esophageal cancer, eligible for palliative radiotherapy of the primary tumor. Cohort B: Inoperable esophageal cancer without metastases, eligible for definitive chemoradiotherapy Cohort C: Operable esophageal cancer eligible for neoadjuvant chemoradiotherapy

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	Nivolumab	Experimental: Nivolumab
RADIATION	Radiotherapy	Radiotherapy
DRUG	Chemotherapy	Chemotherapy
PROCEDURE	Surgery	Surgery

Timeline

• Start date: 2018-04-26
• Primary completion: 2025-12-31
• Completion: 2040-12-31
• First posted: 2018-06-04
• Last updated: 2023-03-22

Locations

1 site across 1 country: Norway