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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
432
PD-1 inhibitors will be administered intravenously, a fixed dose of 200 mg, once every 3 weeks for 1 year.
Paclitaxel 135mg/m2 d1, cisplatin 25mg/m2 d1-3, once every 3 weeks for 4 cycles. or other guideline recommended regimens
TDLN-sparing radiotherapy 50.4Gy/28Fx.
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGPFS for patients with TDLN V15 ≤ 50%
Time frame: 2 years
PFS for all patients
Time frame: 2 years
OS for patients with TDLN V15 ≤ 50%
Time frame: 2 years
OS for all patients
Time frame: 2 years
Adverse events
Time frame: up to 2 years
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