Surgery vs. Radical Chemoradiotherapy for Esophageal SCC After Neoadjuvant Immunochemotherapy

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHenan Cancer Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Severe cardiac or pulmonary insufficiency (Left Ventricular Ejection Fraction < 50%, Forced Expiratory Volume in 1 second < 1 L).

Trial design

Treatments tested in this trial

  • Toripalimab + Nab-paclitaxel + Platinum-based Chemotherapy
  • Radiation with Concurrent Chemotherapy
  • Radical Esophagectomy

Treatment groups

1,044 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators