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

Not Applicable

Recruiting

• Conditions: Esophageal Cancer; Immunotherapy; Gastroesophageal Cancer; Adjuvant
• Interventions: Drug: Immunotherapy; Drug: Chemotherapy Drugs, Cancer

• Registration Number: NCT04688801
• Lead Sponsor: The Second Hospital of Shandong University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2020-11-15
• Study First Submitted QC: 2020-12-25
• Study First Posted: 2020-12-30
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-14
• Last Update Posted: 2022-11-16
• Primary Completion: 2023-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemotherapy + Immunotherapy ± Radiotherapy Group	Immunotherapy	Chemotherapy + Immunotherapy ± Radiotherapy is used as adjuvant therapy for high risk patients after surgery with or without neoadjuvant therapy.
Chemotherapy± Radiotherapy Group	Chemotherapy Drugs, Cancer	Chemotherapy± Radiotherapy is used as adjuvant therapy for high risk patients after surgery with or without neoadjuvant therapy.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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)

Trial Locations

Locations (1)

The Second Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China