Combining chemotherapy and immunotherapy for esophageal cancer treatment
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)
Run by The Second Hospital of Shandong University · NCT04688801 · Data updated 2026-11-12
This study is testing if combining immunotherapy with chemotherapy can help improve survival for patients with esophageal cancer who had surgery but are at high risk of their cancer coming back.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 25 Years to 80 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | The Second Hospital of Shandong University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Jinan, Shandong) |
| Status | Recruiting |
| Started | July 1, 2020 |
| Main results expected | December 31, 2023 |
| Study ends | December 31, 2027 |
| Registry record updated | November 16, 2022 |
| Trial ID | NCT04688801 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with histologically proven resectable esophageal or esophageal-gastric junction carcinoma who can tolerate surgery.
✕Probably not a fit
Patients with advanced EG-junction carcinoma (Siewert III) or those who cannot tolerate surgery will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of combining immunotherapy with chemotherapy in patients who have undergone surgery for esophageal or esophageal-gastric junction cancer. It focuses on patients who have had a poor response to neoadjuvant therapy and are at high risk of recurrence due to incomplete resection or positive lymph nodes. The study aims to improve disease-free survival as the primary endpoint, while also assessing overall survival, safety, toxicity, and quality of life as secondary endpoints. Participants will be randomly assigned to receive either the combination treatment or standard care.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates and quality of life for patients with high-risk esophageal cancer.
How similar studies have gone: While combining chemotherapy and immunotherapy is a novel approach in this specific context, similar strategies have shown promise in other cancer types.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
The Second Hospital of Shandong University
Jinan, Shandong, China Recruiting
Study contacts
- Study coordinator: Yunpeng Zhao, Doc.
- Email: zhaoyunpengsddx@sdu.edu.cn
- Phone: +8617660081916
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.