Surgery vs. Radical Chemoradiotherapy for Esophageal SCC After Neoadjuvant Immunochemotherapy

NCT07629817 | Not Yet Recruiting Phase 3

• 1 other identifier: 2026-150
• Study Type: interventional
• Target: 1,044
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 3-year Event-Free Survival (EFS) Rate

  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

  3 years after randomization/treatment initiation

Study Arms (3)

Organ Preservation with Radical Chemoradiotherapy

EXPERIMENTAL

Patients achieving clinical complete or partial response (cCR/cPR) after neoadjuvant immunochemotherapy will receive definitive chemoradiotherapy for organ preservation. Radiotherapy (50.4 Gy/28 fractions, IMRT) with concurrent weekly chemotherapy (e.g., paclitaxel + cisplatin). Patients with ycCR after chemoradiotherapy will enter observation. Patients with residual disease will undergo salvage esophagectomy.

Drug: Toripalimab + Nab-paclitaxel + Platinum-based Chemotherapy; Combination Product: Radiation with Concurrent Chemotherapy

Immediate Esophagectomy

EXPERIMENTAL

Patients achieving cCR/cPR after neoadjuvant immunochemotherapy will undergo immediate radical esophagectomy (McKeown or Ivor-Lewis procedure) with 2-field or 3-field lymph node dissection. Postoperative immunotherapy (up to 8 cycles) may be administered based on pathological findings (ypT≥1 or N+).

Drug: Toripalimab + Nab-paclitaxel + Platinum-based Chemotherapy; Procedure: Radical Esophagectomy

Non-Responder Surgery

ACTIVE COMPARATOR

Patients with stable disease (cSD) or progressive disease (cPD) after neoadjuvant immunochemotherapy will undergo immediate radical esophagectomy, which is the standard of care for this subgroup. Postoperative treatment is determined by pathological findings.

Drug: Toripalimab + Nab-paclitaxel + Platinum-based Chemotherapy; Procedure: Radical Esophagectomy

Interventions

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

Immediate Esophagectomy; Non-Responder Surgery; Organ Preservation with Radical Chemoradiotherapy

Radiation with Concurrent Chemotherapy COMBINATION_PRODUCT

Chemotherapy administered concurrently with radiotherapy

Organ Preservation with Radical Chemoradiotherapy

Radical Esophagectomy PROCEDURE

Standard surgical procedure with lymph node dissection

Immediate Esophagectomy; Non-Responder Surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

toripalimab; 130-nm albumin-bound paclitaxel; Platinum Compounds; Radiation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Inorganic Chemicals; Physical Phenomena

Central Study Contacts

Yan Zheng, M.D./Ph.D

CONTACT

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

Song

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 5, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): March 15, 2032
• Study Completion (Estimated): March 15, 2032
• Last Updated: June 10, 2026

Record last verified: 2026-06