A Retrospective Clinical Study Exploring Prognostic Factors in Esophageal Cancer Patients

NCT ID: NCT06960889

Last Updated: 2025-05-07

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

ACTIVE_NOT_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-15

Study Completion Date

2026-06-30

Brief Summary

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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

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Conditions

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Esophageal Cancer (EsC)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Radiotherapy Group

Participants will receive definitive radiotherapy or radiotherapy-based combined modality therapy.

radiotherapy

Intervention Type OTHER

Definitive radiotherapy or radiotherapy-based combined modality therapy

Immunotherapy Group

Participants will receive immune checkpoint inhibitors as monotherapy or in combination with other therapies.

Immunotherapy

Intervention Type DRUG

Immune checkpoint inhibitors as monotherapy or in combination with other therapies

Surgery Group

Participants will undergo radical esophagectomy with or without neoadjuvant/adjuvant therapy.

surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines

Intervention Type PROCEDURE

Radical esophagectomy with or without neoadjuvant/adjuvant therapy

Interventions

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radiotherapy

Definitive radiotherapy or radiotherapy-based combined modality therapy

Intervention Type OTHER

Immunotherapy

Immune checkpoint inhibitors as monotherapy or in combination with other therapies

Intervention Type DRUG

surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines

Radical esophagectomy with or without neoadjuvant/adjuvant therapy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nanfang Hospital, Southern Medical University

Guangzhou, Guangzhou, China

Site Status

Countries

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China

References

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Wang ZX, Cui C, Yao J, Zhang Y, Li M, Feng J, Yang S, Fan Y, Shi J, Zhang X, Shen L, Shu Y, Wang C, Dai T, Mao T, Chen L, Guo Z, Liu B, Pan H, Cang S, Jiang Y, Wang J, Ye M, Chen Z, Jiang D, Lin Q, Ren W, Wang J, Wu L, Xu Y, Miao Z, Sun M, Xie C, Liu Y, Wang Q, Zhao L, Li Q, Huang C, Jiang K, Yang K, Li D, Liu Y, Zhu Z, Chen R, Jia L, Li W, Liao W, Liu HX, Ma D, Ma J, Qin Y, Shi Z, Wei Q, Xiao K, Zhang Y, Zhang Y, Chen X, Dai G, He J, Li J, Li G, Liu Y, Liu Z, Yuan X, Zhang J, Fu Z, He Y, Ju F, Liu Z, Tang P, Wang T, Wang W, Zhang J, Luo X, Tang X, May R, Feng H, Yao S, Keegan P, Xu RH, Wang F. Toripalimab plus chemotherapy in treatment-naive, advanced esophageal squamous cell carcinoma (JUPITER-06): A multi-center phase 3 trial. Cancer Cell. 2022 Mar 14;40(3):277-288.e3. doi: 10.1016/j.ccell.2022.02.007. Epub 2022 Mar 3.

Reference Type BACKGROUND
PMID: 35245446 (View on PubMed)

Lu Z, Wang J, Shu Y, Liu L, Kong L, Yang L, Wang B, Sun G, Ji Y, Cao G, Liu H, Cui T, Li N, Qiu W, Li G, Hou X, Luo H, Xue L, Zhang Y, Yue W, Liu Z, Wang X, Gao S, Pan Y, Galais MP, Zaanan A, Ma Z, Li H, Wang Y, Shen L; ORIENT-15 study group. Sintilimab versus placebo in combination with chemotherapy as first line treatment for locally advanced or metastatic oesophageal squamous cell carcinoma (ORIENT-15): multicentre, randomised, double blind, phase 3 trial. BMJ. 2022 Apr 19;377:e068714. doi: 10.1136/bmj-2021-068714.

Reference Type BACKGROUND
PMID: 35440464 (View on PubMed)

Li QQ, Liu MZ, Hu YH, Liu H, He ZY, Lin HX. Definitive concomitant chemoradiotherapy with docetaxel and cisplatin in squamous esophageal carcinoma. Dis Esophagus. 2010 Apr;23(3):253-9. doi: 10.1111/j.1442-2050.2009.01003.x. Epub 2009 Aug 28.

Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Eyck BM, van Lanschot JJB, Hulshof MCCM, van der Wilk BJ, Shapiro J, van Hagen P, van Berge Henegouwen MI, Wijnhoven BPL, van Laarhoven HWM, Nieuwenhuijzen GAP, Hospers GAP, Bonenkamp JJ, Cuesta MA, Blaisse RJB, Busch OR, Creemers GM, Punt CJA, Plukker JTM, Verheul HMW, Spillenaar Bilgen EJ, van der Sangen MJC, Rozema T, Ten Kate FJW, Beukema JC, Piet AHM, van Rij CM, Reinders JG, Tilanus HW, Steyerberg EW, van der Gaast A; CROSS Study Group. Ten-Year Outcome of Neoadjuvant Chemoradiotherapy Plus Surgery for Esophageal Cancer: The Randomized Controlled CROSS Trial. J Clin Oncol. 2021 Jun 20;39(18):1995-2004. doi: 10.1200/JCO.20.03614. Epub 2021 Apr 23.

Reference Type BACKGROUND
PMID: 33891478 (View on PubMed)

Yang H, Liu H, Chen Y, Zhu C, Fang W, Yu Z, Mao W, Xiang J, Han Y, Chen Z, Yang H, Wang J, Pang Q, Zheng X, Yang H, Li T, Zhang X, Li Q, Wang G, Chen B, Mao T, Kong M, Guo X, Lin T, Liu M, Fu J. Long-term Efficacy of Neoadjuvant Chemoradiotherapy Plus Surgery for the Treatment of Locally Advanced Esophageal Squamous Cell Carcinoma: The NEOCRTEC5010 Randomized Clinical Trial. JAMA Surg. 2021 Aug 1;156(8):721-729. doi: 10.1001/jamasurg.2021.2373.

Reference Type BACKGROUND
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Biere SS, van Berge Henegouwen MI, Maas KW, Bonavina L, Rosman C, Garcia JR, Gisbertz SS, Klinkenbijl JH, Hollmann MW, de Lange ES, Bonjer HJ, van der Peet DL, Cuesta MA. Minimally invasive versus open oesophagectomy for patients with oesophageal cancer: a multicentre, open-label, randomised controlled trial. Lancet. 2012 May 19;379(9829):1887-92. doi: 10.1016/S0140-6736(12)60516-9. Epub 2012 May 1.

Reference Type BACKGROUND
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Kwon Y, Yun JK, Jeon YH, Kim YH. Long-term oncologic outcomes of robot-assisted versus conventional open esophagectomy for esophageal cancer: Propensity-score matched anaylsis. Eur J Surg Oncol. 2025 May;51(5):109591. doi: 10.1016/j.ejso.2025.109591. Epub 2025 Jan 9.

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Reference Type BACKGROUND
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Other Identifiers

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NFEC-2025-163

Identifier Type: -

Identifier Source: org_study_id

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