NCT06964568

CCRT Followed by PD-1 Inhibitor Maintenance Therapy in Locally Advanced ESCC

Concurrent Chemoradiotherapy Followed by PD-1 Inhibitor Maintenance Therapy in Locally Advanced Esophageal Squamous Cell Carcinoma: a Randomized Phase III Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 452 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if concurrent chemoradiotherapy followed by immunotherapy as maintenance therapy works to treat locally advanced esophageal squamous cell cancer in adults.

Conditions

• Esophageal Carcinoma
• Radiotherapy
• Immunotherapy

Interventions

Type	Name	Description
DRUG	PD-1 inhibitor	PD-1 inhibitors will be administered intravenously, a fixed dose of 200 mg, once every 3 weeks for 1 year.
RADIATION	Unlimited radiotherapy	Unlimited radiotherapy 50.4Gy/28Fx
DRUG	TP regimen	Chemotherapy: Paclitaxel 135mg/m2 d1+cisplatin 25mg/m2 d1-3 q28d
RADIATION	TDLN-sparing radiotherapy	Tumor draining lymph nodes-sparing radiotherapy 50.4Gy/28Fx

Timeline

• Start date: 2025-02-01
• Primary completion: 2029-02-01
• Completion: 2031-02-01
• First posted: 2025-05-09
• Last updated: 2026-04-17

Locations

1 site across 1 country: China