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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy± Radiotherapy Group | Active Comparator | Chemotherapy± Radiotherapy is used as adjuvant therapy for high risk patients after surgery with or without neoadjuvant therapy. |
|
| Chemotherapy + Immunotherapy ± Radiotherapy Group | Experimental | Chemotherapy + Immunotherapy ± Radiotherapy is used as adjuvant therapy for high risk patients after surgery with or without neoadjuvant therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemotherapy Drugs, Cancer | Drug | Chemotherapy± Radiotherapy after surgery |
|
| 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 |
| 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） |
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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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yunpeng Zhao, Doc. | Contact | +8617660081916 | 17660081916 | zhaoyunpengsddx@sdu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of Shandong University | Recruiting | Jinan | Shandong | 250033 | China |
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| Immunotherapy | Drug | Chemotherapy + Immuonotherapy ± Radiotherapy after surgery |
|
Quality of Life （KPS or PS or QOL or EORTC QLQ C30）after therapy
| 5 years after therapy |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000970 | Antineoplastic Agents |
| D007167 | Immunotherapy |
| ID | Term |
|---|---|
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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