Observing the efficacy and safety of 2 cycles versus 4 cycles of Adebrelimab combined with chemotherapy as neoadjuvant treatment for patients with resectable locally advanced thoracic esophageal squamous cell carcinoma.
This study is a prospective, multicenter, exploratory clinical trial. It involves patients with resectable locally advanced thoracic esophageal squamous cell carcinoma confirmed by histopathology or cytology. The study aims to compare the efficacy and safety of 2 cycles versus 4 cycles of Adebrelimab combined with chemotherapy as neoadjuvant treatment for these patients. Eligible patients will be randomly assigned in a 1:1 ratio to either the 2-cycle group or the 4-cycle group. The primary endpoint is pathological complete response (pCR), with a planned enrollment of 80 patients. The study consists of a screening period (from the signing of the informed consent form to the first administration of the drug, not exceeding 21 days), a treatment period (including neoadjuvant therapy and surgery), and a follow-up period (including safety follow-up, tumor progression/recurrence follow-up, and survival follow-up).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Each treatment cycle is 3 weeks long (Q3W), with a total of 2 cycles. Adebrelimab: 1200 mg once on Day 1, administered intravenously, Q3W. Albumin-bound Paclitaxel: 130 mg/m² on Day 1 and Day 8, administered intravenously, Q3W. Cisplatin: 75 mg/m² on Day 1, administered intravenously, Q3W. Drug infusion should follow this sequence: Adebrelimab → Albumin-bound Paclitaxel → Cisplatin, with a minimum interval of 30 minutes between each infusion.
Each treatment cycle is 3 weeks long (Q3W), with a total of 4 cycles. Adebrelimab: 1200 mg once on Day 1, administered intravenously, Q3W. Albumin-bound Paclitaxel: 130 mg/m² on Day 1 and Day 8, administered intravenously, Q3W. Cisplatin: 75 mg/m² on Day 1, administered intravenously, Q3W. Drug infusion should follow this sequence: Adebrelimab → Albumin-bound Paclitaxel → Cisplatin, with a minimum interval of 30 minutes between each infusion.
Tangdu Hospital Affiliated to the Fourth Military Medical University
Xi'an, Shannxi, China
RECRUITINGPathological complete response rate(pCR)
The lack of all signs of cancer in tissue samples removed during surgery or biopsy after treatment with radiation or chemotherapy.
Time frame: 7 days after surgery
Major pathologic response (MPR)
MPR is defned as less than 10% residual viable tumor after neoadjuvant therapy.
Time frame: 7 days after surgery
R0 resection rate
Proportion of R0 level surgery performed.
Time frame: postoperative 6 hours
Event-free survival (EFS)
The length of time after primary treatment for a caancer ends that the patient remains free of certain complicationsor events that the treatment was intended toprevent or delay.
Time frame: up to 2 years
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