Toripalimab With Preoperative Chemoradiotherapy for LA-EGJ

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Combination of Toripalimab With Preoperative Chemoradiotherapy for Locally Advanced Adenocarcinoma of Esophagogastric Junction

Conditions
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PD-1, Chemoradiotherapy, Gastroesophageal Junction Cancer

Intervention / Treatment
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* Drug: PD-1


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination of toripalimab with preoperative chemoradiotherapy<br>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<br>* 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.<br>* Other names: Toripalimab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TRG (Tumor Regression Grading) | The TRG of operation after neoadjuvant chemoradiotherapy and immunotherapy. | 10 days after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Through study completion, an average of 1 year | 
| LC (Local Control) | The local control of the patients | Through study completion, an average of 1 year | 
| DFS (Disease Free Survival) | The disease free survival of the patients | Through study completion, an average of 1 year |