NCT04688801 Ajuvant Chemotherapy and Immunotherapy in Patients With Esophageal, Esophageal- Gastric Junction Cancer
| NCT ID | NCT04688801 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Second Hospital of Shandong University |
| Condition | Esophageal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2020-07-01 |
| Primary Completion | 2023-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2020-07-01 with a primary completion date of 2023-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04688801 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, up to 80 Years, studying Esophageal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04688801 currently recruiting?
Yes, NCT04688801 is actively recruiting participants. Contact the research team at zhaoyunpengsddx@sdu.edu.cn for enrollment information.
Where is the NCT04688801 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT04688801 clinical trial?
NCT04688801 is sponsored by The Second Hospital of Shandong University. The trial plans to enroll 200 participants.
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