Combining postoperative radiotherapy and immunotherapy for advanced esophageal cancer
Postoperative Radiotherapy Followed by Immunotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma: A Phase II Study
This study is testing if combining radiation therapy with immunotherapy after surgery can help people with advanced esophageal cancer live longer and have fewer side effects.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Anhui Provincial Hospital Government |
| Drugs / interventions | nivolumab, immunotherapy |
| Locations | 1 site (Hefei, Anhui) |
| Trial ID | NCT05937438 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the safety and efficacy of combining postoperative radiotherapy with immunotherapy in patients who have undergone esophagectomy for locally advanced esophageal squamous cell carcinoma. A total of 70 patients will be enrolled and randomly assigned to either the experimental group receiving both treatments or the control group receiving only postoperative radiotherapy. The study will assess outcomes such as disease-free survival and potential side effects associated with the combined treatment approach. The trial is designed to provide insights into improving patient prognosis following surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 who have undergone esophagectomy for squamous cell carcinoma and meet specific pathological staging criteria.
Not a fit: Patients with non-squamous cell carcinoma or those who have not undergone esophagectomy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance disease-free survival rates for patients with locally advanced esophageal cancer.
How similar studies have performed: Previous studies have shown promising results with postoperative immunotherapy, indicating potential for success with this combined approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-75 years old. * After esophagectomy. * Confirmation of squamous cell carcinoma by pathological examination. * Pathological staging of pIIb-IVa. * Over 12 lymph nodes dissected during surgery. * ECOG 0-1. * Signature of inform consent by patients Exclusion Criteria: * Younger than 18 years old or older than 75 years old. * Without esophagectomy. * Non-squamous cell carcinoma. * Pathological staging of pI, IIa, IVb. * Less than 12 lymph nodes dissected during surgery. * ECOG 2-3 g. no signature of inform consent.
Where this trial is running
Hefei, Anhui
- Anhui Provicial Hospital — Hefei, Anhui, China (Recruiting)
Study contacts
- Principal investigator: Dong Qian, M.D. — The First Affiliated Hospital of USTC
- Study coordinator: Dong Qian, M.D.
- Email: qiandong@ustc.edu.cn
- Phone: +86-19156007756
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.