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NCT Number: NCT06710665

Tumor Regression Grade As Predictor of Adjuvant Therapy

Neoadjuvant therapy followed by surgery is preferred for locally advanced esophageal squamous cell carcinoma, but the necessity of adjuvant therapy remains controversial. Tumor regression grade reflects the response to neoadjuvant therapy and may predict patient prognosis, yet its role in guiding adjuvant therapy remains unexplored.

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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 and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

We aim to explore the role of TRG and other clinical characteristics in predicting the efficacy of postoperative adjuvant therapy in ESCC patients receiving neoadjuvant therapy. This study Includes patients who underwent R0 esophagectomy for thoracic ESCC after neoadjuvant therapy. Patients will be assessed by TRG and divided into good responders (TRG 0-1) and poor responders (TRG 2-3). The main variable of interest is adjuvant therapy, and the primary outcome is OS, defined as time from diagnosis until death. Cox proportional hazards regression models will be used to calculate hazard ratios and 95% confidence intervals to assess the impact of various variables on survival time.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

(I) underwent R0 resection with either two-field or three-field lymphadenectomy (II) received neoadjuvant therapy such as preoperative radiotherapy, chemoradiotherapy, or combined immunotherapy (III) had esophageal squamous cell carcinoma pathology.

Exclusion criteria

(I) Patients with incomplete clinical data or follow-up information (II) Diagnosed with multiple primary malignancies

Treatment and study plan

Chemotherapy

Drug

Chemotherapy

Primary outcomes

  1. Overall survival

    Time frame: for patients surviving at least 90 days after surgery

    time from diagnosis until death

Study contacts

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

Maohui Chen

CONTACT

[email protected]

18659181171

Yizhou Huang

CONTACT

[email protected]

13959568242

Sponsors and collaborators

Lead sponsor

Fujian Medical University Union Hospital

Other

Collaborators

  • Quanzhou First Hospital
  • The First Affiliated Hospital of Xiamen University

Registry information

Official study title

Tumor Regression Grade As Predictor of Adjuvant Therapy Benefits in Patients with Esophageal Squamous Cell Carcinoma After Neoadjuvant Therapy

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 29, 2024
Registry last updated
Nov 29, 2024

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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