Actively Recruiting
Ajuvant Chemotherapy and Immunotherapy in Patients With Esophageal, Esophageal- Gastric Junction Cancer
Led by The Second Hospital of Shandong University · Updated on 2022-11-16
200
Participants Needed
1
Research Sites
391 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Ajuvant Chemotherapy and Immunotherapy in Patients With Esophageal, Esophageal- Gastric Junction Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically proven esophageal or EG-junction carcinoma (Siewert I-II)
- Heart and lung function sufficient to tolerate surgery
- Cancer is resectable and planned for curative therapy
- Age between 25 and 80 years
You will not qualify if you...
- EG-junction carcinoma classified as Siewert III
- M1 stage cancer according to the current TNM classification (8th version)
- Heart and lung function insufficient to tolerate surgery
- R2 resection status (incomplete tumor removal)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Second Hospital of Shandong University
Jinan, Shandong, China, 250033
Actively Recruiting
Research Team
Y
Yunpeng Zhao, Doc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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