NCT04688801Recruiting
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)
Source: ClinicalTrials.gov · Last updated 16 Nov 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 15 Nov 2020
- Start date
- 1 Jul 2020
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- The Second Hospital of Shandong University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT04688801
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 1 Jul 2020 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 25 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.