Adjuvant, Esophageal Cancer, Gastroesophageal Cancer, Immunotherapy
Conditions
Brief summary
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.
Interventions
Chemotherapy± Radiotherapy after surgery
DRUGImmunotherapy
Chemotherapy + Immuonotherapy ± Radiotherapy after surgery
Sponsors
The Second Hospital of Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| disease free survival rate | 5 years after surgery | disease free survival after surgery |
| overall survival rate | 5 years after surgery | overall survival after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of adverse events | within 6 months | Rate of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI- CTCAE v5.0) |
| Quality of Life （KPS or PS or QOL or EORTC QLQ C30） | 5 years after therapy | Quality of Life （KPS or PS or QOL or EORTC QLQ C30）after therapy |
Countries
China
Contacts
Primary ContactYunpeng Zhao, Doc.
Outcome results
None listed