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RECRUITING
NCT04688801
NA

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

Sponsor: The Second Hospital of Shandong University

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

25 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2020-07-01

Completion Date

2027-12-31

Last Updated

2022-11-16

Healthy Volunteers

No

Interventions

DRUG

Chemotherapy Drugs, Cancer

Chemotherapy± Radiotherapy after surgery

DRUG

Immunotherapy

Chemotherapy + Immuonotherapy ± Radiotherapy after surgery

Locations (1)

The Second Hospital of Shandong University

Jinan, Shandong, China