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Tumor Regression Grade As Predictor of Adjuvant Therapy

NCT ID: NCT06710665

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-10-10

Brief Summary

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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

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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.

Conditions

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Esophageal Squamous Cell Carcinoma (ESCC)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Good responders

Good responders (TRG 0-1). The pathologic report of the patient after neoadjuvant combined surgery

Chemotherapy

Intervention Type DRUG

Chemotherapy

Poor responders

Poor responders (TRG 2-3). The pathologic report of the patient after neoadjuvant combined surgery

Chemotherapy

Intervention Type DRUG

Chemotherapy

Interventions

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Chemotherapy

Chemotherapy

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Xiamen University

OTHER

Sponsor Role collaborator

Quanzhou First Hospital

OTHER

Sponsor Role collaborator

Fujian Medical University Union Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bin Zheng

Role: STUDY_DIRECTOR

Key Laboratory of Cardio-Thoracic Surgery, Fujian Medical University, Fujian Province University, Fu

Locations

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Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Maohui Chen

Role: CONTACT

Phone: 18659181171

Email: [email protected]

Yizhou Huang

Role: CONTACT

Phone: 13959568242

Email: [email protected]

Facility Contacts

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Maohui Chen, Prof

Role: primary

Yizhou Huang

Role: backup

Other Identifiers

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TRGAT

Identifier Type: -

Identifier Source: org_study_id