A Retrospective Clinical Study Exploring Prognostic Factors in Esophageal Cancer Patients

Active, not recruiting

• Conditions: Esophageal Cancer (EsC)
• Interventions: Other: radiotherapy; Drug: Immunotherapy; Procedure: surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines

• Registration Number: NCT06960889
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

This single-center, retrospective, 7-year observational study aims to investigate prognostic factors in esophageal cancer patients. Adults (≥18 years) with histologically confirmed esophageal cancer who received antitumor therapy between January 2017 and December 2024 were consecutively enrolled. Patient-level data (clinical characteristics, routine laboratory tests, tumor information, and treatment details) were retrospectively collected from electronic medical records to analyze key factors influencing treatment efficacy.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study Start: 2025-04-15
• Study First Submitted: 2025-04-29
• Study First Submitted QC: 2025-04-29
• Last Update Submitted: 2025-04-29
• Study First Posted: 2025-05-07
• Last Update Posted: 2025-05-07
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. Waiver of informed consent for deceased or lost-to-follow-up patients (January 2017-March 2024)
2. Voluntary signed informed consent from surviving patients who could be contacted
3. Treatment at Nanfang Hospital, Southern Medical University (January 2017-December 2024)
4. Received antitumor therapy for esophageal cancer
5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2

Exclusion Criteria

1. Concurrent other malignancies
2. Patients deemed ineligible by investigators

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Radiotherapy Group	radiotherapy	Participants will receive definitive radiotherapy or radiotherapy-based combined modality therapy.
Immunotherapy Group	Immunotherapy	Participants will receive immune checkpoint inhibitors as monotherapy or in combination with other therapies.
Surgery Group	surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines	Participants will undergo radical esophagectomy with or without neoadjuvant/adjuvant therapy.

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	From the date of treatment initiation to the date of death from any cause,assessed up to 120 months.	The length of time from the start of treatment until death from any cause, evaluating the long-term survival benefit of the combined therapy.

Secondary Outcome Measures

Name	Time	Method
Pathologic Complete Response ( pCR )	Perioperative	The absence of residual viable tumor cells in both the primary esophageal tumor and regional lymph nodes after completion of surgery, indicating a complete pathological response.
Major Pathological Response Rate (MPR)	Perioperative	The proportion of patients with ≤10% residual viable tumor cells in resected specimens
Progression-Free Survival (PFS)	From treatment initiation to disease progression or death, assessed up to 100 months	The duration from treatment start until radiologically confirmed disease progression (per RECIST v1.1) or death from any cause, evaluating therapeutic efficacy in delaying tumor growth.

Trial Locations

Locations (1)

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangzhou, China