This is a multi-center, Phase II clinical study aiming to evaluate the efficacy, safety, and organ preservation feasibility of definitive concurrent chemoradiotherapy versus surgery in patients with locally advanced resectable esophageal squamous cell carcinoma (ESCC) who achieve clinical complete response/partial response (cCR/PR) after neoadjuvant chemo-immunotherapy.
A total of 120 eligible subjects will be enrolled. Patients with cCR/PR after 2-3 cycles of neoadjuvant chemo-immunotherapy will be grouped based on personal willing: the control group (n=60) will receive radical esophagectomy + mediastinal lymph node dissection; the experimental group (n=60) will receive definitive concurrent chemoradiotherapy (radiotherapy: 50.4 Gy/28f; chemotherapy: nab-paclitaxel 175mg/m² + carboplatin AUC=5, q21d for 2 cycles). All the patients will receive camrelizumab maintenance therapy (200mg q21d) up to 1 year.
Volunteered to participate, cooperated with follow-up visits.
Aged 18 - 75 years (inclusive), male or female.
Histologically confirmed locally advanced resectable ESCC, clinically staged as Stage II - IVa (cT1N1-3M0, cT2-4aN0-3M0 before treatment; 8th AJCC), and achieve cCR/PR after 2-3 cycles of platinum-based chemotherapy combined with anti-PD-1 or PD-L1 monoclonal antibodies.
Presence of measurable and/or non-measurable lesions as defined by Japanese Classification of Esophageal Cancer (12th Edition);
Surgery for esophageal cancer;
Esophageal fistulae due to infiltration of the primary tumor；
Risk of gastrointestinal bleeding, esophageal fistula or esophageal perforation;
Poor nutritional status, weight loss of ≥10% in the previous 2 months, with no significant improvement after nutritional intervention;
Parallel
Surgery
Procedure/SurgeryRadical esophagectomy + mediastinal lymph node dissection
Radiotherapy
RadiationRadiotherapy: 50.4 Gy/28f
Chemotherapy
DrugChemotherapy: nab-paclitaxel 175mg/m² + carboplatin AUC=5, q21d for 2 cycles
Immunotherapy
DrugCamrelizumab maintenance therapy (200mg q21d) up to 1 year.
DFS
Disease-Free Survival
OS
Overall Survival
LRR
locoregional disease recurrence
R0 resection
Surgical and pathological outcome
AEs
Adverse Events
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Tianjin Medical University Cancer Institute and Hospital
Lead sponsor
Shanxi Province Cancer Hospital
Collaborator
Sichuan Province Cancer Hospital
Collaborator
Henan Province Cancer Hospital
Collaborator