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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07629817

Acronym

HCHTOG2603

Enrollment

1044

Registered

2026-06-05

Start date

2026-06-16

Completion date

2032-03-15

Last updated

2026-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Squamous Cell Carcinoma

Brief summary

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.

Interventions

DRUGToripalimab + Nab-paclitaxel + Platinum-based Chemotherapy

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

COMBINATION_PRODUCTRadiation with Concurrent Chemotherapy

Chemotherapy administered concurrently with radiotherapy

PROCEDURERadical Esophagectomy

Standard surgical procedure with lymph node dissection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Age 18-75 years, any sex. 2. ECOG Performance Status 0-1. 3. Histologically confirmed, previously untreated thoracic esophageal squamous cell carcinoma (ESCC). 4. 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. 5. 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. 6. Signed written informed consent form (ICF).

Exclusion criteria

1. History of other malignancy within the past 5 years. 2. Active autoimmune disease. 3. Active Hepatitis B Virus (HBV) / Hepatitis C Virus (HCV) / Human Immunodeficiency Virus (HIV) infection. 4. Severe cardiac or pulmonary insufficiency (Left Ventricular Ejection Fraction \< 50%, Forced Expiratory Volume in 1 second \< 1 L). 5. Pregnancy or lactation.

Design outcomes

Primary

Measure	Time frame	Description
3-year Event-Free Survival (EFS) Rate	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

Countries

China

Contacts

CONTACTYan Zheng, M.D./Ph.D

hnszlyylixiang@163.com(+86)0371-65587610

CONTACTSong