Locally advanced Esophageal Squamous Cell Carcinoma (ESCC) has poor prognosis with standard therapies. Neoadjuvant immunochemotherapy improves pathological response rates, but optimal regimens remain undefined. Paclitaxel polymeric micelles offer enhanced tumor targeting (EPR effect) and reduced toxicity vs. conventional paclitaxel formulations, with no need for premedication. This single-arm, prospective trial evaluates the efficacy and safety of neoadjuvant sintilimab combined with paclitaxel polymeric micelles and cisplatin in resectable locally advanced ESCC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
1. Sindilimab : 200 mg, Q3W, intravenous infusion, D1 ; 2. Paclitaxel polymeric micelles : 300 mg/m2 ; q3W, intravenous infusion, D1 ; 3. Cisplatin : 75 mg/m2 ; q3W ; intravenous infusion, D1 ;
The Fourth Hospital of Hebei Medical University
Hebei, Shijiazhuang, China
Pathological Complete Response (pCR) rate
Pathological Complete Response (pCR) rate: Proportion of patients with no residual invasive tumor in primary tumor bed and sampled lymph nodes (ypT0/Tis ypN0) after neoadjuvant therapy
Time frame: Assessed via surgical pathology (4-6 weeks post-neoadjuvant therapy)
Major Pathological Response (MPR) rate
Time frame: Perioperative
R0 resection rate
Time frame: Perioperative
Objective Response Rate (ORR) per RECIST v1.1
Time frame: Assessed at baseline and pre-surgery
Event-Free Survival (EFS)
Time frame: Follow-up every 3 months for 2 years, then every 6 months up to 5 years
Overall Survival (OS)
Time frame: Follow-up every 3 months for 2 years, then every 6 months up to 5 years
Safety: Incidence of adverse events (AEs), serious AEs (SAEs), and immune-related AEs (irAEs)
Time frame: From initiation of treatment to 30 days post-last dose (or 90 days for SAEs)
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