This study aims to investigate the safety and efficacy of sintilimab combined with platinum-based chemotherapy in neoadjuvant treatment of potentially resectable esophageal cancer.
This study was designed as an open-lable, single-arm, exploratory clinical study. Sintilimab in combination with liposomal paclitaxel, cisplatin and S-1 will be given every 3 weeks to our patients for 2 cycles as neoadjuvant therapy. A radical dissection is scheduled within 6 weeks after last neoadjuvant treatment. This study will be devided for 3 phases: safety run-in, efficacy pilot and efficacy confirmation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Sintilimab (200mg) will be given intravenously on day 1 in 3-week cycles for two cycles.
Liposomal Paclitaxel (135mg/m2), ivd, d1 + Cisplatin (25mg/m2), ivd, d1-3 + S-1 capsule (40mg), po, d1-14, repeated every 3 weeks for two cycles.
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
Safety and feasibility
Safety is defined as the incidence of Grade 3-4 Treatment-Related Adverse Events (TRAEs) from the day of neoadjuvant therapy to 30 days after surgery or within 90 days after last neoadjuvant treatment. Feasibility of surgery is defined as the incidence of TRAEs causing surgery delay of ≥30 days and/or inoperable patients.
Time frame: 20 months
MPR rate
Major Pathological Response (MPR) is defined as the presence of 10% or fewer viable cancer cells in the hematoxylin and eosin (H\&E)-stained slides from the resected tumor following neoadjuvant treatment.
Time frame: 20 months
R0 resection rate
R0 resection is defined as no cancer cells are seen microscopically at the resection margin following surgery.
Time frame: 20 months
Recurrence-Free Survival (RFS)
Recurrence-Free Survival (RFS) is calculated from surgery to the date of recurrence or death.
Time frame: 5 years
Overall Survival (OS)
Overall Survival (OS) is calculated from the beginning of neoadjuvant treatment to the date of death from any cause.
Time frame: 5 years
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