Esophageal cancer is the most prevalent cancer globally with poor survival outcome. The prognosis with surgery alone is poor, accounting for 30-40% of overall survival at 5 year. Either neoadjuvant chemotherapy (nCT) or chemoradiotherapy (nCRT) has been shown as efficatious therapy to improve patients outcomes in esophageal or esophagogastric junction cancer as compared with surgery alone. The purpose of this study was to explore the optimal neoadjuvant treatment modalities including PD-1/PD-L1 antibody or targeted drug for patients with esophageal or esophagogastric junction cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,000
q1-3W according to physician's preference
q1-3W according to physician's preference
40-50Gy/1.8-2.2Gy/20-25f
Radical esophagectomy
Anti-PD-1/PD-L1 Antibody
W1-5 qW or d1-14, q3W according to physician's preference
200-400mg, d1,qW
Department 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
RECRUITINGOverall survival
Time frame: 5 year
Progression free survival
Time frame: 1 year, 2 year, 3 year, 5 year
Number of participants with Acute and late toxicities of radiotherapy,chemotherapy and immunotherapy
Acute and late toxicities are evaluated by NCI-CTC version 5.0
Time frame: 3 months
Pathological response rate
Pathological response were classified into three grades.Grade I signifies that there is little shrinkage in the tumor; only mild regression in the tumor cells is observed under themicroscope. Grade II shows gross reduction in size of the tumor and marked regression in the cancer cells microscopically, yet viable nests of cancer tissue are still visible. Grade III implies complete or almost total resolution of the tumor on exploration, and disappearance of the tumor tissue microscopically; only remnants of degenerated cancer cells can be seen (so-called ghost cancer cells).
Time frame: 3 months
R0 resection rate
Time frame: 3 months
Locoregional recurrence free survival
Time frame: 1 year, 2 year, 3 year, 5 year
Distant metastasis free survival
Time frame: 1 year, 2 year, 3 year, 5 year
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