This is a prospective, phase II, exploratory clinical trial. The study aims to evaluate the efficacy and safety of in combination adebrelimab with nimotuzumab and chemotherapy as neoadjuvant therapy in patients with resectable esophageal squamous cell carcinoma. The primary endpoint is pCR ( pathological complete response), evaluating the efficacy of adebrelimab in combination with nimotuzumab and neoadjuvant chemotherapy in patients with resectable esophageal squamous cell carcinoma. After the primary objective is achieved, EFS (event free survival ), R0 resection rate, MPR (major pathological response), OS (overall survival), and safety will be assessed as key secondary objectives. The study plans to enroll 22 patients with resectable esophageal squamous cell carcinoma. The study is divided into a screening period, a treatment period, and a follow-up period. Subjects will enter the screening period after signing informed consent. Subjects who pass the screening assessment will be enrolled in the study. Eligible subjects will receive two cycles of neoadjuvant therapy with adebrelimab, nimotuzumab, nab-paclitaxel, and cisplatin. Esophagectomy will be performed after two cycles of neoadjuvant therapy (4-6 weeks after the last dose). Researchers will determine subsequent treatment based on postoperative pathology. After treatment (surgery), safety and efficacy follow-ups will commence. When a subject first experiences disease progression as assessed by the investigator according to RECIST v1.1, confirmation is required after 4-6 weeks (except for rapid or significant clinical progression). Subjects whose disease progression is not confirmed by imaging after 4-6 weeks may continue treatment if their clinical symptoms remain stable, as determined by the investigator, until imaging-confirmed disease progression occurs, or other termination criteria as specified in the protocol are met, whichever occurs first.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Adebrelimab: 1200mg, iv, d1, Q3W, 2cycles Nimotuzumab:400 mg, d1,d8, Q3W, 2cycles Cisplatin: 75mg/m2,d1, Q3W, 2cycles Albumin-bound paclitaxel: 260 mg/m2, d1, Q3W, 2cycles
pCR, Pathological Complete Response
Time frame: From patient enrollment to the end of surgery, assessed up to 12 months
MPR,Main Pathological Response Rate
Time frame: From patient enrollment to the end of surgery, assessed up to 12 months
Margin-free (R0) resection rate
Time frame: From patient enrollment to the end of surgery, assessed up to 12 months
EFS, Event free survival
Time frame: The time from the start of treatment to the first occurrence of any of the following events: disease progression beyond surgical intervention, local or distant recurrence, death from any cause, etc. assessed up to 36 months
OS, Overall Survival
Time frame: From the start of treatment to death from any cause,assessed up to 60 months
Adverse events rate (CTCAE 5.0)
All treatment-related adverse events, immune-related adverse events, and adverse events of grade 3 or higher, as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: From the start of enrollment to the completion of the study,assessed up to 60 months
Xiangming liu Tianjin Medical University Cancer Institute and Hospital
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