Combining chemotherapy and immunotherapy for esophageal cancer treatment
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)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 25 Years to 80 Years |
| Sex | All |
| Sponsor | The Second Hospital of Shandong University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT04688801 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with histologically proven resectable esophageal or esophageal-gastric junction carcinoma who can tolerate surgery.
Not a fit: Patients with advanced EG-junction carcinoma (Siewert III) or those who cannot tolerate surgery will not benefit from this study.
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 performed: While combining chemotherapy and immunotherapy is a novel approach in this specific context, similar strategies have shown promise in other cancer types.
Eligibility criteria
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 this trial is running
Jinan, Shandong
- The Second Hospital of Shandong University — Jinan, Shandong, China (Recruiting)
Study contacts
- Study coordinator: Yunpeng Zhao, Doc.
- Email: zhaoyunpengsddx@sdu.edu.cn
- Phone: +8617660081916
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.