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Tumor Regression Grade As Predictor of Adjuvant Therapy

F

Fujian Medical University (FJMU)

Status

Enrolling

Conditions

Esophageal Squamous Cell Carcinoma (ESCC)

Treatments

Drug: Chemotherapy

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

400 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Yizhou Huang; Maohui Chen

Data sourced from clinicaltrials.gov

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