To evaluate the safety and feasibility of DCF combined with camrelizumab in the treatment of locally advanced ESCC
Primary outcome: To evaluate the safety and feasibility of DCF combined with camrelizumab in the treatment of locally advanced ESCC Secondary outcome: pathologic complete response (pCR)、Major Pathologic Response(MPR)、R0 resection rate、Objective response rate(ORR)、Disease free survival(DFS)、Relief rate and safety of dysphagia
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
55
Camrelizumab 200mg IV D1,Q3W,and preoperative therapy with three cycles.
DCF:Oxaliplatin (85mg/ m\^2, IV D1,Q3W.Docetaxel: 60 mg/m\^2 intravenous infusion for 60 minutes, D1,Q3W.Tegafur:BSA\<1.25\^2,40 mg/time,1.25\^2\<BSA\<1.5\^2,50 mg/time,BID ,after breakfast and dinner, continuous administration for 14 days, rest for 7 days, as a treatment cycle;Repeat every 3 weeks
Xijing Hospital
Xi'an, Shaanxi, China
RECRUITINGSafety and Feasibility(Incidence of Treatment-Emergent Adverse Events)
All participants with treatment-related adverse events as assessed by National Cancer Institute Common Terminology Criteria for Adverse Event,Version 5.0(CTC AE5.0).
Time frame: 12months
Pathologic Complete Response (PCR)
PCR is defined as pT0N0M0
Time frame: 1 month after resection
Major pathologic response (MPR)
MPR is defined as viable tumor comprised ≤ 10% of resected tumor specimens.
Time frame: 1 month after resection
Disease Free Survival (DFS)
Percentage of Participants With DFS, as Assessed by RECIST 1.1. DFS is defined as the time from randomization to the first documented disease progression of local recurrence or distant metastasis or death due to any cause.
Time frame: 3 and 5 years
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