Organ preservation strategies for esophageal cancer treatment
Official title: An Organ Preservation Strategies After Chemoradiotherapy Combined With Immunotherapy for Esophageal Cancer vs Cross Therapy.
Run by Ruijin Hospital · NCT06339060 · Data updated 2026-11-12
This study is testing a new treatment approach that combines chemotherapy, radiation, and immunotherapy to see if it can help people with advanced esophageal cancer avoid surgery and improve their quality of life.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 356 (estimated) |
| Sponsor | Ruijin Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Shanghai) |
| Status | Recruiting |
| Started | May 1, 2024 |
| Main results expected | March 1, 2028 |
| Study ends | March 1, 2028 |
| Registry record updated | July 3, 2024 |
| Trial ID | NCT06339060 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with histologically confirmed resectable locally advanced esophageal squamous cell carcinoma and an ECOG performance status of 0-1.
✕Probably not a fit
Patients with active autoimmune diseases, prior treatments for esophageal cancer, or certain medical conditions may 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 neoadjuvant chemoradiotherapy with immunotherapy followed by an organ preservation strategy in patients with locally advanced esophageal squamous cell carcinoma. Participants will be randomly assigned to either receive the experimental treatment or undergo standard surgery after chemoradiotherapy. The study aims to evaluate various clinical outcomes, including overall survival rates and quality of life, over a three-year period. Data will be collected on treatment effects, surgical results, and long-term oncological effects through rigorous statistical analysis.
Why it matters
Potential benefit: If successful, this approach could improve survival rates and quality of life for patients with esophageal cancer while potentially avoiding the need for radical surgery.
How similar studies have gone: While there have been studies on chemoradiotherapy and immunotherapy for esophageal cancer, this specific organ preservation strategy is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * A patient will be eligible for inclusion in this study only if ALL of the following criteria apply: * Histologically confirmed cT2-T4a,N0-N+,M0 resectable esophageal squamous cell carcinoma. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Patients approve and sign the informed consent Exclusion Criteria: * Patients with active autoimmune disease or history of autoimmune disease. * Patients who have a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications. * Subjects with a history of symptomatic interstitial lung disease. * History of allergy to study drug components. * Women must not be pregnant or breast-feeding. * Men with female partners (WOCBP) that are not willing to use contraception. * Patient has received prior chemotherapy, radiotherapy, target therapy and immune therapy for this malignancy or for any other past malignancy. * medical conditions that, in the Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events
Where it's running
-
Ruijin hospital
Shanghai, China Recruiting
Study contacts
- Principal investigator: Hecheng Li, MD/PHD — Ruijin Hospital Shanghaijiaotong University School of Medicine
- Study coordinator: Hecheng Li
- Email: lihecheng2000@hotmail.com
- Phone: 19121652450
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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.