The primary objective is to compare PD-1 inhibitor combined with preoperative chemoradiotherapy followed by surgery versus neo-adjuvant chemoradiotherapy followed by surgery, in terms of the overall survival time (OS) in patients with Stage T1-4aN1-3M0 or T3-4aN0M0 squamous cell esophageal carcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
422
Sintilimab 200mg, IV (in the vein) on day 1 and day 22
External radiation with a total dose of 40.0 or 45.0 Gy is given in 20 fractions,5 fractions a week.
50mg/m2, IV (in the vein) on day 1,day 8,day 15 and day 22
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGOverall survival
Overall survival will be calculated from the date of randomization and an event registered on the date of death from any cause. Patients lost to follow up, or those with no death recorded on the day the database is frozen, will be censored on the date of last follow up.
Time frame: At end of enrollment- up to 5 years in follow up
Progression free survival
Progression free survival is defined as the time from randomization until objective tumor progression or death.
Time frame: At end of enrollment- up to 5 years in follow up
Pathologic complete response rate
No malignant tumor cells were detected in the removed specimens including primary tumor and lymph nodes
Time frame: Two weeks after surgery
R0 resection rate
The percentage of patients who undergo complete resection
Time frame: Two weeks after surgery
Incidence of perioperative complications
Incidence of complications
Time frame: Ninety days after surgery
Perioperative mortality
Incidence of death postoperatively
Time frame: Ninety after surgery
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25mg/m2,IV DRIP on day 1,day 8,day 15 and day 22
McKeown esophagectomy, Ivor Lewis esophagectomy or minimally invasive esophagectomy will be performed 6-8 weeks after chemoradiotherapy. Two-field lymphadenectomy with total mediastinal lymph node dissection is performed during surgery.