The purpose of this study was to evaluate the effect and safety of concurrent PD-1 antibody-based long-term radiotherapy followed by 2 cycles SOX with PD-1 in patients with locally advanced adenocarcinoma of esophagogastric junction.
Histologically confirmed adenocarcinoma of esophagogastric junction, and Her-2 negative.
Clinically diagnosed stage T3+orN+M0, according to CT/MRI scan.
No prior anti-tumor treatment, including surgery, chemotherapy, radiotherapy, and targeted therapy.
Eastern Cooperative Oncology Group(ECOG) performance status(PS) 0-1.
Existence of other active malignant tumors within 5 years or at the same time.
Already received chemotherapy, radiation therapy, targeted or immunotherapy.
Have any active autoimmune disease or history of autoimmune disease.
Patients with congenital or acquired immunodeficiency.
Single group
neoadjuvant Radiation plus SOX and PD-1 antibody
DrugPatients will be given the perioperative treatment as below once recruited: First, neoradiation (5w) will be given: intensity modulated radiotherapy was given for tumors and high-risk lymphatic drainage areas. PD-1 antibody will be started concurrent the radiation for 2 cycles. The neochemotherapy (SOX) and PD-1 antibody will be given for 2 cycles after 1 week since radiation completed ; Patients will rest 2 weeks after the last cycle of neochemotherapy, and evaluation will be performed during this time. And D2 surgery will be performed if resectable. SOX and PD-1 antibody will be given q3w. Adjuvant chemotherapy: We advise starting 4 cycles of SOX regimen in 3-8w after surgery.
Pathological Complete Responce (pCR) Rate
Proportion of patients with AEG who received neoadjuvant theray with radiation plus PD-1 antibody and SOX regimen and postoperative pathological examination shows pathological complete responce
R0 Resection Rate
Proportion of patients with AEG who received surgery with pathological pathological examination proved microscopically margin-negative resection
Progression Free Survival (PFS)
Disease Free Survival was defined as the time from the date of surgery to the date of the local recurrence, and/or distant disease, or tumor-related death.
Adverse Events
For any adverse reactions, the researchers refer to the National Cancer Institute (NCI) standard of common toxicity (CTC)
Surgery Morbidity
Surgical morbidity reported according to Clavien-Dindo classification
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
