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NCT Number: NCT07236320

Neoadjuvant Immunochemotherapy vs Chemoradiotherapy in ESCC

This retrospective real-world study aimed to compare neoadjuvant immunochemotherapy (NICT) and neoadjuvant chemoradiotherapy (NCRT) followed by esophagectomy in patients with locally advanced esophageal squamous cell carcinoma (ESCC). A total of 203 consecutive patients treated at Sichuan Cancer Hospital between March 2018 and March 2022 were analyzed (NICT: 59; NCRT: 144). The primary endpoints were overall survival (OS) and disease-free survival (DFS); secondary endpoints included pathological complete response (pCR), tumor regression grade (TRG), and R0 resection rate. After inverse probability of treatment weighting adjustment, baseline characteristics were balanced between groups. Both groups achieved comparable long-term OS and DFS, while NCRT showed higher rates of local pathological response. Exploratory subgroup analysis suggested that patients achieving pCR after NICT might have superior survival outcomes. The study indicates that NICT provides similar long-term survival compared to NCRT and may offer immunologic advantages for selected responders, warranting further validation in prospective multicenter trials.

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Key information

Conditions

Esophageal Squamous Cell Carcinoma (ESCC) Carcinoma Carcinoma, Squamous Cell Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Esophageal Squamous Cell Carcinoma 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–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sichuan Cancer Hospital and Institute

Chengdu, Sichuan, 610041, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18-80 years
  • Histologically confirmed thoracic ESCC
  • Clinical stage cT1N+M0 or cT2-4aN0-3M0
  • Received neoadjuvant therapy (immunochemotherapy or chemoradiotherapy) followed by esophagectomy

Exclusion criteria

  • History of other malignancies
  • Did not complete neoadjuvant therapy or required salvage surgery
  • Incomplete baseline or follow-up data

Treatment and study plan

Neoadjuvant immunochemotherapy

Drug

NACI group patients received treatment of minimally 2 cycles of ICIs agent (mainly camrelizumab or toripalimab, 200 mg every 3 weeks (200 mg every 3 weeks)) combined with concurrent chemotherapy.

Neoadjuvant Chemoradiotherapy

Drug

NCRT group patients followed the concurrent NCRT treatment, and the total neoadjuvant radiotherapy dose was 40.0-50.4Gy with 1.8-2.14 Gy fractions and 5 fractions/week.

Primary outcomes

  1. Overall Survival (OS)

    Time frame: 5 years

    Time from first treatment to death from any cause or last follow-up.

  2. Disease-Free Survival (DFS)

    Time frame: 5 years

    Time from surgery to recurrence, death, or last follow-up.

Secondary outcomes

  1. Pathological Complete Response (pCR) rate

    Time frame: 3 months

  2. Tumor Regression Grade (TRG)

    Time frame: 3 months

  3. R0 resection rate

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Yongtao Han

Other

Registry information

Official study title

Neoadjuvant Immunochemotherapy Versus Chemoradiotherapy in Locally Advanced Esophageal Cancer: A Real-World Study

Important dates

Study start
2018
Primary completion
2022
Study completion
2025
First posted
Nov 19, 2025
Registry last updated
Nov 19, 2025

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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