Ajuvant Chemotherapy and Immunotherapy in Patients With Esophageal, Esophageal- Gastric Junction Cancer

Study Overview
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Brief Summary
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Surgery with or without neoadjuvant therapy is usually used as the treatment for resectable esophageal cancer or esophageal- gastric junction cancer. Patients who have a poor response to neoadjuvant therapy and have an incomplete (R1) resection or have metastatic lymph nodes in the resection specimen (N+) are especially at risk of recurrence, to continue with the chemotherapy± radiotherapy is often used in these cases. However, the overall survival is still poor. We designed a prospective randomized controlled tial to study whether immunotherapy could be used with chemotherapy after surgery to improve overall survival. The primary endpoint ofthe study is disease free survival, with secondary endpoints of overall survival, safety and toxicity, and quality of life.

Official Title
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Ajuvant Chemotherapy and Immunotherapy in Patients With Esophageal, Esophageal- Gastric Junction Cancer With or Without Preoperative Chemotherapy With High Risk for Recurrence (N+ and/ or R1)

Conditions
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Esophageal Cancer, Gastroesophageal Cancer, Immunotherapy, Adjuvant

Intervention / Treatment
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* Drug: Chemotherapy Drugs, Cancer
* Drug: Immunotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven esophageal or EG-junction carcinoma (Siewert I-II). The heart and lung function can tolerate surgery. The cancer is resectable and incurable therapy will be perfomed. Exclusion Criteria: EG-junction carcinoma (Siewert III). M1 stage according to the current (8th) version of TNMclassification system. The heart and lung function can't tolerate surgery. R2 Resection Status.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 80 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chemotherapy± Radiotherapy Group<br>Chemotherapy± Radiotherapy is used as adjuvant therapy for high risk patients after surgery with or without neoadjuvant therapy. | Drug: Chemotherapy Drugs, Cancer<br>* Chemotherapy± Radiotherapy after surgery<br>|
| Experimental: Chemotherapy + Immunotherapy ± Radiotherapy Group<br>Chemotherapy + Immunotherapy ± Radiotherapy is used as adjuvant therapy for high risk patients after surgery with or without neoadjuvant therapy. | Drug: Immunotherapy<br>* Chemotherapy + Immuonotherapy ± Radiotherapy after surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival rate | disease free survival after surgery | 5 years after surgery | 
| overall survival rate | overall survival after surgery | 5 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse events | Rate of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI- CTCAE v5.0) | within 6 months | 
| Quality of Life （KPS or PS or QOL or EORTC QLQ C30） | Quality of Life （KPS or PS or QOL or EORTC QLQ C30）after therapy | 5 years after therapy |