This is a prospective, single-center, randomized phase 2 study of adebrelimab plus full-course neoadjuvant therapy in resectable locally advanced esophageal squamous cell carcinoma. Patients achieving clinical complete response (cCR) after neoadjuvant treatment will be randomized 1:1 to watchful waiting with 2 cycles consolidation chemo-Immunotherapy or standard surgery. Primary endpoint is 2-year DFS. Secondary endpoints include OS, pCR/MPR, R0 resection rate, safety, and quality of life.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Adebrelimab Injection,intravenous infusion, Day 1, every 3 weeks for 2 cycles. Albumin-bound paclitaxel 260 mg/m², carboplatin AUC = 5, intravenous infusion, Day 1, every 3 weeks for 2 cycles. Two cycles of chemotherapy combined with immunotherapy.
surgery
2-year Disease-Free Survival (DFS) rate in the watchful waiting arm
Time frame: Assessed from randomization to disease recurrence, progression, or death, up to 2 years
2-year Overall Survival (OS) in the watchful waiting arm
Time frame: From randomization to death, up to 2 years
2-year OS in the surgery arm
Time frame: From randomization to death, up to 2 years
R0 resection rate
Time frame: Assessed at surgery
Pathological Complete Response (pCR) rate
Time frame: Assessed at surgery
Major Pathological Response (MPR) rate
Time frame: Assessed at surgery
Event-Free Survival (EFS)
Time frame: From enrollment to progression/recurrence/death, up to 2 years
Clinical Complete Response (cCR) rate
Assessed after completion of neoadjuvant therapy, prior to surgical resection.
Time frame: Within 1-2 weeks prior to surgery, after completion of neoadjuvant therapy.
EORTC QLQ-C30 Quality of Life Score
Assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30). The scale ranges from 0 to 100, with higher scores indicating better quality of life for functional scales and worse symptoms for symptom scales.
Time frame: Baseline, 6 months, 12 months, 24 months
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Treatment Completion Rate
The proportion of patients who complete the planned neoadjuvant therapy regimen as defined in the protocol.
Time frame: From first study treatment to end of neoadjuvant therapy,Evaluation period: up to 12 months.
Adverse Event (AE) and Serious Adverse Event (SAE) Incidence (CTCAE v6.0)
Incidence of all adverse events (AEs) and serious adverse events (SAEs) graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.
Time frame: From first study treatment to 30 days after last study treatment.