NCT05817201

Toripalimab Plus Radiotherapy for Elderly Esophageal Cancer Patients Treated With Non-chemotherapy Strategy

A Phase II and III, Randomized, Multicenter Clinical Study: Toripalimab Plus Radiotherapy for Elderly Esophageal Cancer Patients Treated With Non-chemotherapy Strategy

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Taizhou Hospital · Academic / Other
• Sex: All
• Age: 70 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to explore the therapeutic efficacy of immune checkpoint inhibitors combined with radical radiotherapy in elderly patients with esophageal cancer.

Detailed description

Older patients with esophageal cancer are universally intolerant to chemotherapy. This study is performed to explore a non-chemotherapy strategy for elderly esophageal cancer patients. Participants will be treated with Toripalimab monoclonal antibody maintenance versus S-1 combined with radiotherapy, intended to explore the efficacy and safety of non-chemotherapy strategy for elderly esophageal cancer patients.

Conditions

• Esophageal Cancer
• Radiation Therapy
• Immunotherapy
• Chemotherapy

Interventions

Type	Name	Description
DRUG	Toripalimab	Toripalimab 240mg day7 and day 28，every 3 weeks 1month after radiotherapy，until progression or 1 years or intolerant.
DRUG	Tegafur	Tegafur 70mg/m2/day day 1 to day 14，and day 29 to day42.
RADIATION	IMRT	PGTV 54Gy/2.16Gy/25F/5W, PTV 45Gy/1.8Gy/25F/5W

Timeline

• Start date: 2022-07-01
• Primary completion: 2023-12-31
• Completion: 2024-12-31
• First posted: 2023-04-18
• Last updated: 2023-04-18

Locations

2 sites across 1 country: China