Definitive chemoradiotherapy (CRT) is the standard treatment option for unresectable esophageal cancer (EC). However, as high as more than 40% of EC patients experienced locoregional recurrence after concurrent CRT. Immunotherapy targeting the PD-1/PD-L1 checkpoints has demonstrated promising activity in advanced EC. The aim of this study was to evaluate the efficacy and safety of the combination of toripalimab (an anti-PD-1 antibody) combined with definitive CRT in locally advanced esophageal squamous cell carcinoma (ESCC).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Patients received toripalimab 240 mg on days 1 and 22 during radiotherapy followed by a maintenance phase of toripalimab IV 240 mg every 3 weeks for up to 1 year.
Patients received 5 cycles of paclitaxel/cisplatin (paclitaxel 50mg/m2 and cisplatin 25 mg/m2) on days 1, 8, 15, 22, 29 during radiotherapy.
All patients received external-beam radiation using intensity-modulated radiotherapy. The prescribed dose is 50.4 Gy in 28 fractions over 5-6 weeks.
Sun Yat-sen University Cancer Center
Guanzhou, Guangdong, China
clinical complete response rate
Tumor response was evaluated 3 months after the completion of chemoradiotherapy based on CT or PET-CT scans, endoscopy with biopsies.
Time frame: 3 months after chemoradiotherapy (plus or minus 14 days)
2-year overall survival
The 2-year overall survival of the whole group
Time frame: From date of randomization until the date of death from any cause or the date of last follow-up, whichever came first, assessed up to 24 months
2-year progression-free survival
The 2-year progression-free survival of the whole group
Time frame: From date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months
Duration of response
Tumor response was evaluated every two months after chemoradiotherapy according to RECIST criteria
Time frame: From date of first CR/PR to the date of first PD according to RECIST criteria, assessed up to 24 months
Incidence of treatment-related adverse events as assessed by CTCAE v4.0
Toxicity of treatment was evaluated according to CTCAE 4.0
Time frame: From the start of treatment to 2 year after the completion of treatment
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