The objective of this study is to evaluate the efficacy and safety of radiation therapy combined with anti-PD-1 antibody SHR-1210 in patients with esophageal cancer
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Hangzhou Cancer Hospital
Hangzhou, Zhejiang, China
Objective response rate (ORR)
ORR was evaluated 4-8 weeks after completion of RT and was recorded according to RECIST, version 1.1.
Time frame: 4-8 weeks
Treatment-emergent adverse events
Incidence of treatment-emergent adverse events would be assessed based on the common toxicity criteria for adverse events version 4.0 (CTCAE v4.0) and EORTC criterion.
Time frame: year 0 - year 1
Local-regional free survival (LRFS)
LRFS was calculated from the date of treatment initiation to the date of documented failure.
Time frame: year 0 - year 3
Overall survival
OS was determined as the time (in months) between the first day of therapy and the last follow-up or the date of death.
Time frame: year 0 - year 3
Health-related quality of life (HRQoL)
HRQoL measured by standardized EORTC questionaires (EORTC QLQ-C30)
Time frame: From baseline to one year after RT.
Health-related quality of life (HRQoL)
HRQoL measured by standardized EORTC questionaires (EORTC QLQ-OES18)
Time frame: From baseline to one year after RT.
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