Organ preservation strategies for esophageal cancer treatment
An Organ Preservation Strategies After Chemoradiotherapy Combined With Immunotherapy for Esophageal Cancer vs Cross Therapy.
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 |
| Enrollment | 356 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06339060 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with histologically confirmed resectable locally advanced esophageal squamous cell carcinoma and an ECOG performance status of 0-1.
Not a fit: Patients with active autoimmune diseases, prior treatments for esophageal cancer, or certain medical conditions may not benefit from this study.
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 performed: While there have been studies on chemoradiotherapy and immunotherapy for esophageal cancer, this specific organ preservation strategy is relatively novel.
Eligibility criteria
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 this trial is running
Shanghai
- 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
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.