This is an investigator-initiated, single-arm, exploratory clinical study.The study population consisted of esophageal squamous cell carcinoma patients nonresponding to initial neoadjuvant chemoradiotherapy. The purpose of this study was to evaluate the efficacy and safety of immunotherapy combined with chemotherapy in the adjuvant treatment of esophageal squamous cell carcinoma after surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
immunotherapy:PD-1 inhibitor chemotherapy:5-Fu and DDP
Disease-free Survival (DFS)
Disease-free survival is defined as the time between date of surgery and first date of recurrence or death, whichever occurs first.Recurrence is defined as the appearance of one or more new lesions, which can be local, regional, or distant in location from the primary resected site ( assessed by imaging or pathology). All deaths without prior recurrence are considered as DFS events.
Time frame: up to approximately 46 months
Overall survival (OS)
Overall survival is defined as the time from date of surgery to date of death from any cause. For subjects that are alive, their survival time was censored at the date of last contact date (or "last known alive date").
Time frame: up to approximately 46 months
Overall Survival Rate
Overall survival rate is defined as the percentage of participants who are alive at 1, 2 and 3 years following surgery
Time frame: From date of surgery to 1, 2 and 3 years later
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