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

The Second Hospital of Shandong University

Status: Enrolling

Conditions: Esophageal Cancer; Immunotherapy; Gastroesophageal Cancer; Adjuvant

Treatments: Drug: Chemotherapy Drugs, Cancer; Drug: Immunotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04688801

Ajuvant immunotherapy ZYP

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 25 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Chemotherapy± Radiotherapy Group

Active Comparator group

Description:

Chemotherapy± Radiotherapy is used as adjuvant therapy for high risk patients after surgery with or without neoadjuvant therapy.

Treatment:

Drug: Chemotherapy Drugs, Cancer

Chemotherapy + Immunotherapy ± Radiotherapy Group

Experimental group

Description:

Chemotherapy + Immunotherapy ± Radiotherapy is used as adjuvant therapy for high risk patients after surgery with or without neoadjuvant therapy.

Treatment:

Drug: Immunotherapy