NCT06676449

TDLN-sparing RT Plus Immunotherapy and Chemotherapy in Locally Advanced ESCC

Tumor Draining Lymph Nodes Sparing Radiotherapy Plus Immunotherapy and Chemotherapy in Locally Advanced Esophageal Squamous Cell Carcinoma: a Randomized Phase III Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 432 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if immunotherapy in combination with tumor draining lymph nodes-sparing radiotherapy (TDLN-sparing RT) and chemotherapy works to treat locally advanced esophageal squamous cell cancer in adults. Researchers will compare immunotherapy in combination with TDLN-sparing RT and chemotherapy to TDLN-sparing RT and chemotherapy to see if immunotherapy works more effectively when using TDLN-sparing RT to treat locally advanced esophageal squamous cell cancer Participants will: TDLN-sparing RT for esophageal cancer 50.4Gy/28Fx Paclitaxel plus cisplatin every 3 weeks for 4 cycles PD-1 inhibitors or observation every 3 weeks for 1 year

Conditions

• Esophageal Carcinoma
• Radiotherapy
• Immunotherapy

Interventions

Type	Name	Description
DRUG	Immunotherapy	PD-1 inhibitors will be administered intravenously, a fixed dose of 200 mg, once every 3 weeks for 1 year.
DRUG	chemotherapy: Paclitaxel/Cisplatin or other guideline recommended regimens	Paclitaxel 135mg/m2 d1, cisplatin 25mg/m2 d1-3, once every 3 weeks for 4 cycles. or other guideline recommended regimens
RADIATION	TDLN-sparing RT	TDLN-sparing radiotherapy 50.4Gy/28Fx.

Timeline

• Start date: 2024-11-01
• Primary completion: 2028-10-31
• Completion: 2030-10-30
• First posted: 2024-11-06
• Last updated: 2026-01-07

Locations

1 site across 1 country: China