This is a prospective, single-arm, multicenter clinical study conducted in China. Patients with pathologically or cytologically confirmed resectable esophageal squamous cell carcinoma will be enrolled to explore the efficacy and safety of adebrelimab combined with thymalfasin and chemotherapy as neoadjuvant therapy for resectable esophageal squamous cell carcinoma. The study consists of a screening period (from the signing of informed consent by subjects to the first study drug administration, no more than 21 days), a treatment period (including neoadjuvant therapy and surgery), and a follow-up period (comprising safety follow-up and survival follow-up). During neoadjuvant therapy, patients will receive 2 to 3 cycles of adebrelimab combined with thymalfasin and chemotherapy, followed by surgical resection.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
Adebrelimab: 1200 mg, intravenous infusion on Day 1, every 3 weeks (Q3W)
Thymalfasin: 1.6 mg, subcutaneous injection twice weekly for every 3-week cycle.
Nab-paclitaxel: 260 mg/m², intravenous infusion on Day 1, every 3 weeks (Q3W); Cisplatin: 75 mg/m², intravenous infusion on Day 1 / Day 2 / Day 3, every 3 weeks (Q3W); OR Carboplatin: AUC = 5-6, intravenous infusion on Day 1, every 3 weeks (Q3W).
Affiliated Hospital of Putian University
Putian, Fujian, China
Pathologic Complete Response (pCR) Rate
Defined as the proportion of subjects with Grade I pathological response per the pathological response evaluation criteria after neoadjuvant therapy, i.e., no residual viable tumor in the primary tumor lesion.
Time frame: 2 weeks after surgery
R0 Resection Rate
No residual viable tumor cells at the surgical resection margins
Time frame: 2 weeks after surgery
Major Pathologic Response (MPR)Rate
Defined as the percentage of subjects with ≤10% residual viable tumor (Grade I and Grade II pathological response).
Time frame: 2 weeks after surgery
Disease-Free Survival(DFS)
Defined as the time from the date of surgery (the first disease-free day) to local or distant disease recurrence, or death from any cause, whichever occurs first.
Time frame: Defined as the time from the date of surgery (the first disease-free day) to local or distant disease recurrence, or death from any cause, whichever occurs first.Assessed for a maximum of 60 months.
Objective Response Rate(ORR)
Defined as the proportion of subjects achieving complete response (CR) or partial response (PR) based on imaging assessments performed from study enrollment to prior to surgery, evaluated per RECIST version 1.1 criteria.
Time frame: At the end of Cycle 2-3 (each cycle is 21 days)
Overall Survival(OS)
Defined as the time from the date of first study drug administration to death from any cause.
Time frame: From date of first study drug administration until death from any cause, assessed up to study completion。Assessed for a maximum of 60 months.
Incidence and Grade of Adverse Events and Serious Adverse Events [Safety and Tolerability]
Assessed according to NCI-CTCAE Version 5.0 criteria
Time frame: From informed consent signature through 90 days after the last dose of adebrelimab
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