NCT07629817RecruitingPhase 3
Surgery vs. Radical Chemoradiotherapy for Esophageal SCC After Neoadjuvant Immunochemotherapy
A Multicenter, Open-Label, Randomized Controlled Phase III Clinical Trial Comparing Surgery Versus Radical Chemoradiotherapy (Organ Preservation) in Patients With Thoracic Esophageal Squamous Cell Carcinoma Achieving cCR or cPR Following Neoadjuvant Immunochemotherapy
Source: ClinicalTrials.gov · Last updated 31 Jul 2026
Brief summary (registry, in English)
This is a Phase III, multicenter, open-label, randomized controlled trial. The study aims to compare organ preservation versus esophagectomy in patients with locally advanced, resectable thoracic esophageal squamous cell carcinoma (ESCC) who achieve a complete or partial clinical response (cCR/cPR) following neoadjuvant immunochemotherapy.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1044 (estimated)
- First submitted
- 1 Jun 2026
- Start date
- 16 Jun 2026
- Primary completion date
- 15 Mar 2032
- Lead sponsor
- Henan Cancer Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07629817
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1044
- From 16 Jun 2026 to the primary completion date, 15 Mar 2032
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of other malignancy within the past 5 years.
- Active autoimmune disease.
- Active Hepatitis B Virus (HBV) / Hepatitis C Virus (HCV) / Human Immunodeficiency Virus (HIV) infection.
Lab values
- Severe cardiac or pulmonary insufficiency (Left Ventricular Ejection Fraction \< 50%, Forced Expiratory Volume in 1 second \< 1 L).
Other
- Pregnancy or lactation.
Who the study is looking for
- Age 18-75 years, any sex.
- ECOG Performance Status 0-1.
- Histologically confirmed, previously untreated thoracic esophageal squamous cell carcinoma (ESCC).
- Clinical stage cT2N0M0, T3N0-2M0 (AJCC 8th Edition), assessed as resectable with a potential for R0 resection by endoscopic ultrasound (EUS), PET-CT, and contrast-enhanced CT. Patients with cervical lymph node metastasis may also be included if deemed suitable for three-field lymphadenectomy by a multidisciplinary team assessment.
- Adequate bone marrow, hepatic, and renal function:
- Absolute neutrophil count ≥ 1.5 × 10⁹/L, Platelet count ≥ 100 × 10⁹/L, Hemoglobin ≥ 90 g/L.
- Alanine aminotransferase / Aspartate aminotransferase ≤ 2.5 × Upper Limit of Normal, Total bilirubin ≤ 1.5 × Upper Limit of Normal.
- Serum creatinine ≤ 1.5 × Upper Limit of Normal or Creatinine clearance ≥ 60 mL/min.
- Signed written informed consent form (ICF).
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.