A Phase 1/2 interventional study of PD-1 in PD-1, Chemoradiotherapy and Gastroesophageal Junction Cancer, sponsored by Peking University. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-08-20.
Sponsored by Peking University · Phase 1/2, Interventional, and Treatment
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.
Peking University is the lead sponsor of 411 studies on the registry; 122 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Age 18-75, male and female.
Exclusion Criteria:
Patients have received immunotherapy, such as PD-1 antibody, PD-L1 antibody and CTLA4 antibody.
This is a one arm study, enrolled locally advanced EGJ patients will receive toripalimab and combined with preoperative chemoradiotherapy and operation. generic name：PD-1 dosage form：Injection dosage：240mg (6ml) frequency：every 3 weeks duration：4 times before operation and 4 times after operation
Drug: PD-1
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.
Also known as: Toripalimab
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Peking University