Chemoradiotherapy, Gastroesophageal Junction Cancer, PD-1
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGPD-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.
Sponsors
Peking University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 1\) Age 18-75, male and female. 2\) ECOG score was 0-1. 3\) Diagnosis of adenocarcinoma in the gastroesophageal junction. 4\) Initial treatment of locally advanced patients (cT3-4 or N+, and M0). 5\) The estimated survival time will be more than 12 months. 6\) Adequate organ reserve function. 7\) agree to join the group, willing to cooperate with clinical research, and sign the informed consent.
Exclusion criteria
* 1\) Patients have received immunotherapy, such as PD-1 antibody, PD-L1 antibody and CTLA4 antibody. 2\) Immunosuppressive drugs were used within 4 weeks before admission. 3\) Active infection, acute myocardial infarction in recent 6 months, severe arrhythmia requiring long-term drug intervention, severe stroke, uncontrolled epilepsy or other serious medical complications. 4\) In the past five years, there have been other malignant diseases except for cured skin cancer and cervical cancer in situ.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TRG (Tumor Regression Grading) | 10 days after operation | The TRG of operation after neoadjuvant chemoradiotherapy and immunotherapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with AEs (Adverse Events) | Through study completion, an average of 1 year | The AEs during the trial, including radiation mucositis, bone marrow suppression, AEs related to immunotherapy and so on |
| LC (Local Control) | Through study completion, an average of 1 year | The local control of the patients |
| DFS (Disease Free Survival) | Through study completion, an average of 1 year | The disease free survival of the patients |
Contacts
Primary ContactJianhao Geng, MD
Backup ContactZiyu Li, MD
Outcome results
None listed