Although unprecedented advances have been made in the field of esophageal cancer in recent decades, the prognosis for patients with locally advanced esophageal squamous cell carcinoma (ESCC) remains extremely poor, accounting for 30-40% of overall survival at 5 year. In recent years, multimodal treatments have proven to be an appropriate therapeutic approach for locally advanced ESCC. Recently, immunotherapy developed rapidly. The purpose of this study was to observe the efficacy and safety of cardonilizumab combined with chemoradiotherapy in the treatment of locally advanced ESCC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Two cycles of Inductive therapy: nab-paclitaxel 250mg/ m2+cisplatin 75mg/ m2+Cardonilizumab 10mg/kg,ivgtt,3 weeks per cycle for 2 cycles
Chemoradiotherapy ± immunotherapy: * PTV: 50-50.4Gy/1.8-2Gy/25-28fractions ②nab-paclitaxel 100mg+cisplatin 25mg/ m2, d1, every 7 days for 3-5 weeks ③Cardonilizumab 10mg/kg,ivgtt,3 weeks per cycle for 2 cycles
Surgery was evaluated after concurrent chemoradiotherapy according to patients willing and the surgeons' assessment. If patients were accessed with unresectable disease after radiotherapy or refused to receive surgery, Cardonilizumab would be administered for 2 years or until disease progression.
Anyang Cancer Hospital
Anyang, Henan, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
NOT_YET_RECRUITINGDepartment of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
Beijing, China
RECRUITINGEvent-free survival
Time from treatment initiation to locoregional or distant recurrence, or death from any cause.
Time frame: 1-year
Overall survival
The 1-year OS rate was defined as the proportion of patients who still alive within one year from treatment initiation.
Time frame: 1-year
Adverse events
In terms of adverse events of radiation, chemotherapy and immunotherapy
Time frame: 1-year
Locoregional recurrence free survival
The 1-year rate was defined as the proportion of patients who did not have any locoregional recurrence from treatment initiation.
Time frame: 1-year
Distant metastasis free survival
The 1-year rate was defined as the proportion of patients who did not have any distant metastasis from treatment initiation.
Time frame: 1-year
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