This is an investigator-initiated, single-arm, single-center, exploratory clinical study.The study population consisted of patients with R0 resection of esophageal squamous cell carcinoma who had not received radiation therapy.The purpose of this study was to evaluate the efficacy and safety of carrelizumab combined with radiotherapy in the adjuvant treatment of esophageal squamous cell carcinoma after surgery.About 20 subjects are planned to be enrolled in this study.Drug regimen: Patients with esophageal squamous cell carcinoma received radiotherapy combined with carrilizumab adjuvant therapy for 6 cycles 1-3 months after R0 resection.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
PD-1antibodies,200mg ivgtt Q3W
45-55Gy/1.8~2.0Gy
Fuzhou General Hospital
Fuzhou, Fujian, China
RECRUITING1-year disease-free survival rate (1-year DFS)
The percentage of subjects who were free of disease recurrence or death from the start of study enrolment to 12 months later.
Time frame: up to approximately 1 year
Progression-Free Survival (PFS)
the time from treatment to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. Patients who have not experienced disease progression or death at the time of analysis will be censored at the time of last tumor assessment.
Time frame: up to approximately 2 year
Disease-free survival (DFS)
The time from enrolment (ICF signing) to disease recurrence or death due to disease progression.
Time frame: up to approximately 2 year
Overall survival (OS)
the time between subjects' death from various causes.For subjects still alive at the last follow-up, their OS was measured as data deletion by the time of the last follow-up.
Time frame: up to approximately 3 year
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