This study is aimed to evaluate the efficacy and safety of sintilimab combined with chemotherapy versus chemotherapy in perioperative treatment of locally advanced esophageal squamous cell carcinoma.
This study was designed as an open-label, randomized controlled, phase II trial. Subjects will be systematically randomized at a ratio of 1:1 and will be assigned to either the experimental group (sintilimab combined with chemotherapy group) or the control group (chemotherapy alone group). They will receive 2-3 cycles of neoadjuvant therapy followed by radical esophagectomy and lymph node dissection and adjuvant therapy determined by investigators. The primary endpoint is 1-year Event-free survival (EFS) rate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
182
Sintilimab (200mg) will be given intravenously on day 1 in 3-week cycles for 2-3 cycles.
Cisplatin (75mg/m2) wih routine hydration for 3 days and nab-paclitaxel (260mg/m2) will be given intravenously on day 1 in 3-week cycles for 2-3 cycles.
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Event-free survival (EFS)
EFS is defined as the time from R0 resection to disease recurrence or metastases or death for subjects achieving radical resection or the time from enrollment to disease progression or death for subjects not achieving radical resection.
Time frame: 12 months
R0 surgery rate
R0 resection is defined as no cancer cells are seen microscopically at the resection margin following surgery.
Time frame: 20 months
pCR rate
Pathological Complete Response (pCR) is defined as no viable cancer cells in the hematoxylin and eosin (H\&E)-stained slides from the resected tumor and lymph nodes following neoadjuvant treatment.
Time frame: 20 months
Disease-free survival (DFS)
DFS is calculated from R0 surgery to the date of recurrence or metastases or death in subjects with radical resection.
Time frame: 24 months
Overall Survival (OS)
OS is calculated from the randomization to the date of death from any cause.
Time frame: 24 months
adverse events
The incidence of treatment-related adverse events (TRAEs), severe adverse events (SAE), based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: 24 months
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