Neoadjuvant chemoradiotherapy (CRT) followed by surgery has become the standard treatment option for locally advanced esophageal cancer (EC). However, only 20% to 40% of EC patients can achieve pathologic complete response (pCR) after neoadjuvant CRT with favorable prognosis. 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 neoadjuvant CRT in locally advanced esophageal squamous cell carcinoma (ESCC).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Patients received toripalimab 240 mg IVDRIP on days 1 and 22 during neoadjuvant radiotherapy.
Patients received 4 cycles of paclitaxel/cisplatin (paclitaxel 50mg/m2 and cisplatin 25 mg/m2) on days 1, 8, 15, 22 during neoadjuvant radiotherapy.
All patients received external-beam radiation using intensity-modulated radiotherapy. The prescribed dose is 44 Gy in 20 fractions over 4 weeks.
A transthoracic (Ivor-Lewis) esophagectomy is performed 6-8 weeks after CRT completion.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGPathologic complete response rate
The rate of pathologic complete response rate after neoadjuvant chemoradiotherapy.
Time frame: Three working days after surgery
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 disease-free survival
The 2-year disease-free survival of the whole group
Time frame: From date of surgery until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months.
Incidence of Treatment-related Adverse Events as Assessed by CTCAE v4.0
The neoadjuvant treatment-related adverse events
Time frame: From the enrollment to the date of surgery
R0 resection rate
The R0 resection rate of esophagectomy
Time frame: Three working days after surgery
Perioperative complication rate
The perioperative complication rate of esophagectomy
Time frame: From date of surgery to 30 days later
Perioperative mortality
The perioperative mortality of esophagectomy
Time frame: From date of surgery to 30 days later
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