Clinical trial Recruiting at 1 site Phase 3 Interventional Ages 18 to 75

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.

More Esophageal Cancer trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment356 (estimated)
SponsorRuijin Hospital
Academic / other
Drugs / interventionschemotherapy, immunotherapy
Locations1 site (Shanghai)
StatusRecruiting
StartedMay 1, 2024
Main results expectedMarch 1, 2028
Study endsMarch 1, 2028
Registry record updatedJuly 3, 2024
Trial IDNCT06339060 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.