This study aims to investigate the safety and efficacy of radiotherapy combined with Toripalimab (PD-1 inhibitor) in the treatment of locally advanced adenocarcinoma of the gastroesophageal junction.
In this study, patients with locally advanced adenocarcinoma of gastroesophageal junction will be enrolled to explore the safety and efficacy of preoperative radiotherapy and chemotherapy combined with Toripalimab (PD-1). Around 45 patients will be recruited in this one-arm cohort. All patients in this cohort will be treated with preoperative radiotherapy and chemotherapy plus PD-1 for two times, then another two times of PD-1 before operation. After surgery, postoperative chemotherapy plus PD-1 will be carried out for four times. This study focuses on the safety of chemoradiotherapy combined with immunotherapy, and whether the TRG grade, LC, DFS have been improved.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
2 times PD-1 (240mg) combined with preoperative chemoradiotherapy,then another 2 times PD-1 before operation. 4 times PD-1 combined with postoperative chemotherapy.
TRG (Tumor Regression Grading)
The TRG of operation after neoadjuvant chemoradiotherapy and immunotherapy.
Time frame: 10 days after operation
Number of participants with AEs (Adverse Events)
The AEs during the trial, including radiation mucositis, bone marrow suppression, AEs related to immunotherapy and so on
Time frame: Through study completion, an average of 1 year
LC (Local Control)
The local control of the patients
Time frame: Through study completion, an average of 1 year
DFS (Disease Free Survival)
The disease free survival of the patients
Time frame: Through study completion, an average of 1 year
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