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NCT Number: NCT07629817

Surgery vs. Radical Chemoradiotherapy for Esophageal SCC After Neoadjuvant Immunochemotherapy

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.

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Key information

Conditions

Esophageal Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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).
  • Pregnancy or lactation.

Treatment and study plan

Toripalimab + Nab-paclitaxel + Platinum-based Chemotherapy

Drug

This is the standard induction therapy administered to all enrolled patients. It consists of the PD-1 inhibitor Toripalimab combined with Nab-paclitaxel

Radiation with Concurrent Chemotherapy

Combination Product

Chemotherapy administered concurrently with radiotherapy

Radical Esophagectomy

Procedure

Standard surgical procedure with lymph node dissection

Primary outcomes

  1. 3-year Event-Free Survival (EFS) Rate

    Time frame: 3 years after randomization/treatment initiation

    Event-Free Survival is defined as the time from randomization (for responders) or from the start of neoadjuvant therapy (for the overall population) until the occurrence of any of the following events:

    Local recurrence of esophageal cancer. Distant metastasis. Death from any cause

Study contacts

Contact information is provided by the study sponsor or research team.

Song

CONTACT

[email protected]

(+86)0371-65587610

Yan Zheng, M.D./Ph.D

CONTACT

[email protected]

(+86)0371-65587610

Sponsors and collaborators

Lead sponsor

Henan Cancer Hospital

Other Gov

Registry information

Official study title

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

Acronym: HCHTOG2603

Important dates

Study start
2026
Primary completion
2032
Study completion
2032
First posted
Jun 5, 2026
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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