NCT04688801

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

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: The Second Hospital of Shandong University · Academic / Other
• Sex: All
• Age: 25 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophageal Cancer
• Gastroesophageal Cancer
• Immunotherapy
• Adjuvant

Interventions

Type	Name	Description
DRUG	Chemotherapy Drugs, Cancer	Chemotherapy± Radiotherapy after surgery
DRUG	Immunotherapy	Chemotherapy + Immuonotherapy ± Radiotherapy after surgery

Timeline

• Start date: 2020-07-01
• Primary completion: 2023-12-31
• Completion: 2027-12-31
• First posted: 2020-12-30
• Last updated: 2022-11-16

Locations

1 site across 1 country: China