Tumor Regression Grade As Predictor of Adjuvant Therapy

Recruiting

• Conditions: Esophageal Squamous Cell Carcinoma (ESCC)
• Interventions: Drug: Chemotherapy

• Registration Number: NCT06710665
• Lead Sponsor: Fujian Medical University Union Hospital

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.

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-10-01
• Study First Submitted: 2024-11-26
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study First Posted: 2024-11-28
• Last Update Posted: 2024-11-28
• Primary Completion: 2025-10-01
• Study Completion: 2025-10-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Good responders	Chemotherapy	Good responders (TRG 0-1). The pathologic report of the patient after neoadjuvant combined surgery
Poor responders	Chemotherapy	Poor responders (TRG 2-3). The pathologic report of the patient after neoadjuvant combined surgery

Primary Outcome Measures

Name	Time	Method
Overall survival	for patients surviving at least 90 days after surgery	time from diagnosis until death

Trial Locations

Locations (1)

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China