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

Esophageal Cancer Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04688801
• Other study ID #: Ajuvant immunotherapy ZYP
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: December 31, 2027

Study information

• Verified date: November 2022
• Source: The Second Hospital of Shandong University
• Contact: Yunpeng Zhao, Doc.
• Phone: +8617660081916
• Email: zhaoyunpengsddx[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adjuvant
• Esophageal Cancer
• Gastroesophageal Cancer
• Immunotherapy

Intervention

Drug:
• Chemotherapy Drugs, Cancer
Chemotherapy± Radiotherapy after surgery
• Immunotherapy
Chemotherapy + Immuonotherapy ± Radiotherapy after surgery

Locations

Country	Name	City	State
China	The Second Hospital of Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease free survival rate	disease free survival after surgery	5 years after surgery
Primary	overall survival rate	overall survival after surgery	5 years after surgery
Secondary	Rate of adverse events	Rate of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI- CTCAE v5.0)	within 6 months
Secondary	Quality of Life (KPS or PS or QOL or EORTC QLQ C30)	Quality of Life (KPS or PS or QOL or EORTC QLQ C30)after therapy	5 years after therapy