TDLN-sparing RT Plus Immunotherapy and Chemotherapy in Locally Advanced ESCC
NCT06676449 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 432
Last updated 2026-01-07
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
- 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.
Sponsors & Collaborators
-
Fudan University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-11-01
- Primary Completion
- 2028-10-31
- Completion
- 2030-10-30
Countries
- China
Study Locations
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