The purpose of study is to investigate the safety and efficacy of sequential immunotherapy with neoadjuvant chemoradiotherapy for esophageal cancer
This is a single-arm, phase Ib study. Eligibility criteria include histologically confirmed ESCC and clinical T3-4aN0M0 or T2-4aN+M0 (AJCC/UICC 8). Patients received neoadjuvant radiotherapy (41.4Gy in 23 fractions) with concurrent chemotherapy (paclitaxel, 50 mg/m2, carboplatin area under the curve of 2mg/mL/min, QW\*5). Then followed by two cycles of tislelizumab (200mg, Q3W). The primary endpoint was the pathological complete response (pCR) rate and safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
paclitaxel, 50 mg/m2, QW\*5
area under the curve of2mg/mL/min, QW\*5
200mg Q3W, 2cycles
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Complete pathological response rate
Time frame: 1 year
R0 resection rate
Time frame: 1 year
2-year Disease-free survival rate
Time frame: 2 years
2-year overall survival rate
Time frame: 2 years
Safety will be analyzed through the incidence of adverse events, serious adverse events
Time frame: Up to 28 days from last dose
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41.4Gy in 23 fractions