Tumor Regression Grade As Predictor of Adjuvant Therapy

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06710665

Enrollment

400

Registered

2024-11-29

Start date

2024-10-01

Completion date

2025-10-10

Last updated

2024-11-29

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

Conditions

Esophageal Squamous Cell Carcinoma (ESCC)

Brief summary

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.

Detailed description

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.

Interventions

DRUGChemotherapy

Chemotherapy

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Overall survival	for patients surviving at least 90 days after surgery	time from diagnosis until death

Countries

China

Contacts

Primary ContactMaohui Chen

757860733@qq.com18659181171

Backup ContactYizhou Huang

1204382231@qq.com13959568242

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026