This is an investigator-initiated, single-arm, exploratory clinical study.The study population consisted of treatment naive advanced esophageal squamous cell carcinoma patients. The purpose of this study was to evaluate the efficacy and safety of immunotherapy combined with chemotherapy and residual lesions irradiation of esophageal squamous cell carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
TP regimen (cis-platinum ; Tocetaxel ) combined with PD-1 inhibitors(Sintilimab)for 4 cycles, then irradiation of the residual lesions for 50Gy/2Gy/25f. After complete irradiation, sintilimab is administered every 21 days a cycle for additional 13 cycles.
Qingdao Central Hospital, Qingdao Cancer Hospital
Qingdao, Shandong, China
RECRUITINGQingdao Central Hospital
Qingdao, Shandong, China
RECRUITINGOverall survival (OS)
time from enrollment to patients death
Time frame: up to 24 months
Progression-free survival (PFS)
time from disease progression or patient death
Time frame: up to 12 months
overall response rate (ORR)
complete response plus partial response
Time frame: up to 12 weeks
toxicities
toxicities according to CTCAE 5.0
Time frame: up to 12 weeks
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