NCT04851132

Radiotherapy Plus Durvalumab in Elderly Esophageal Squamous Cell Carcinoma

Radiotherapy Plus Durvalumab in Elderly Esophageal Squamous Cell Carcinoma: A Prospective Phase II Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

The incidence and mortality of esophageal cancer are at the forefront in China, among which the elderly patients account for a large proportion. Concurrent chemoradiotherapy is the standard treatment for inoperable locally advanced esophageal cancer. Most elderly patients with esophageal cancer cannot tolerate concurrent chemotherapy because of complications and other reasons. Immunotherapy has definite efficacy and low toxicity in advanced esophageal squamous cell carcinoma, and the results combined with radiotherapy have also been preliminarily reported. Therefore, it is necessary to further explore the efficacy and safety of radiotherapy combined with immunotherapy in elderly patients with esophageal cancer.

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
RADIATION	Radiotherapy	IMRT (Intensity Modulated RT) or 3D-CRT (three-dimensional conformal radiotherapy); 95% PGTV 59.92Gy/2.14Gy/28f; 95% GTVnd 59.92Gy/2.14Gy/28f; 95% PTV 50.40Gy/1.80Gy/28f; 5 days a week; 6 weeks.
DRUG	Durvalumab	Durvalumab 1000 mg, intravenously (IV), on Day 1 of radiotherapy, every 3 weeks for up to 18 administrations.

Timeline

• Start date: 2021-03-11
• Primary completion: 2023-03-01
• Completion: 2023-06-01
• First posted: 2021-04-20
• Last updated: 2021-06-22

Locations

1 site across 1 country: China