The purpose of this study is to explore the effectiveness and safety of neoadjuvant immune combined chemotherapy or radiochemotherapy compared with traditional neoadjuvant radiochemotherapy in patients with locally advanced Esophageal Squamous Cell Carcinoma.
This study aimed to evaluate the efficacy and safety of adding immunotherapy to neoadjuvant chemotherapy (CT) or chemoradiotherapy (CRT) compared to neoadjuvant CRT alone for resectable locally advanced esophageal squamous cell carcinoma (ESCC)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
426
The study perform preoperative neoadjuvant therapy, surgery and postoperative adjuvant therapy on subjects. Preoperative neoadjuvant therapy includes 3 groups: iCamrelizumab combined with neoadjuvant chemotherapy; Camrelizumab combined with neoadjuvant radiochemotherapy, and neoadjuvant radiochemotherapy.
The study perform preoperative neoadjuvant therapy, surgery and postoperative adjuvant therapy on subjects. Preoperative neoadjuvant therapy includes 3 groups: iCamrelizumab combined with neoadjuvant chemotherapy; Camrelizumab combined with neoadjuvant radiochemotherapy, and neoadjuvant radiochemotherapy.
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGAnyang Tumour Hospital
Anyang, China
RECRUITINGSun yat-sen University Cancer Center
Guangzhou, China
RECRUITINGEFS assessed by the investigator according to RECIST 1.1
defined as event free survival,defined as the time from randomization to the occurrence of tumor progression/recurrence /death, whichever comes first
Time frame: median EFS approximately over 45 months
OS
defined as the time from registration to death due to any cause, or censored at date last known alive
Time frame: median OS approximately over 80 months
R0 resection rate
defined as complete surgery resection rate
Time frame: within 28 working days after surgery
DFS
defined as the time from the date of surgery who completed R0 resection to local or distant recurrence, or death due to any cause, whichever occurs first;
Time frame: median DFS approximately over 40 months
HRQoL
defined as quality and nutrition assessment
Time frame: approximately 48 months
pCR
pCR is defined as pathological complete response(ypT0/TisN0)
Time frame: within 28 working days after surgery
MPR
MPR is defined as the percentage of subjects with \<10% residual tumor in the primary tumor site
Time frame: within 28 working days after surgery
Adverse events (AEs)
Incidence and grade (including serious adverse events \[SAEs\] and immune-related adverse events \[irAEs\]), determined according to the NCI-CTCAE 5.0 criteria
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Anhui Provincial Hospital
Hefei, China
RECRUITINGZhongshan Hospital of Fudan University
Shanghai, China
RECRUITINGTime frame: through study completion, assessed up to 50 months