NCT06960889

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
14mo left

Started Apr 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Apr 2025Jun 2027

Study Start

First participant enrolled

April 15, 2025

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 7, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

1.7 years

First QC Date

April 29, 2025

Last Update Submit

April 13, 2026

Conditions

Keywords

Prognostic factorsTreatment strategiesEfficacy comparisonEsophageal cancer

Outcome Measures

Primary Outcomes (1)

  • Overall Survival (OS)

    The length of time from the start of treatment until death from any cause, evaluating the long-term survival benefit of the combined therapy.

    From the date of treatment initiation to the date of death from any cause,assessed up to 120 months.

Secondary Outcomes (3)

  • Pathologic Complete Response ( pCR )

    Perioperative

  • Major Pathological Response Rate (MPR)

    Perioperative

  • Progression-Free Survival (PFS)

    From treatment initiation to disease progression or death, assessed up to 100 months

Study Arms (3)

Radiotherapy Group

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

Other: radiotherapy

Immunotherapy Group

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

Drug: Immunotherapy

Surgery Group

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

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

Interventions

Definitive radiotherapy or radiotherapy-based combined modality therapy

Radiotherapy Group

Immune checkpoint inhibitors as monotherapy or in combination with other therapies

Immunotherapy Group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Esophageal Cancer Patients

You may qualify if:

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

You may not qualify if:

  • Concurrent other malignancies
  • Patients deemed ineligible by investigators

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangzhou, 510515, China

Location

Related Publications (14)

  • Shi X, Zhao H, Yu J, Cai P, Zhou S, Yang N, Li D. Changes in PD-1 expression on T lymphocyte subsets and related immune indicators before and after definitive chemoradiotherapy for esophageal squamous cell carcinoma. Ann Med. 2025 Dec;57(1):2445190. doi: 10.1080/07853890.2024.2445190. Epub 2024 Dec 23.

    PMID: 39713872BACKGROUND
  • Lin FC, Chang WL, Chiang NJ, Lin MY, Chung TJ, Pao TH, Lai WW, Tseng YL, Yen YT, Sheu BS. Radiation dose escalation can improve local disease control and survival among esophageal cancer patients with large primary tumor volume receiving definitive chemoradiotherapy. PLoS One. 2020 Aug 6;15(8):e0237114. doi: 10.1371/journal.pone.0237114. eCollection 2020.

    PMID: 32760099BACKGROUND
  • Dong J, Li C, Wang B, Li Y, Wang S, Cui H, Gao M. Prognostic analysis of esophageal cancer patients after neoadjuvant therapy. Front Immunol. 2025 Feb 21;16:1553086. doi: 10.3389/fimmu.2025.1553086. eCollection 2025.

    PMID: 40061941BACKGROUND
  • 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, Lordick F, D'Journo XB, Cerfolio RJ, Korst RJ, Novoa NM, Swanson SJ, Brunelli A, Ismail M, Fernando HC, Zhang X, Li Q, Wang G, Chen B, Mao T, Kong M, Guo X, Lin T, Liu M, Fu J; AME Thoracic Surgery Collaborative Group. Neoadjuvant Chemoradiotherapy Followed by Surgery Versus Surgery Alone for Locally Advanced Squamous Cell Carcinoma of the Esophagus (NEOCRTEC5010): A Phase III Multicenter, Randomized, Open-Label Clinical Trial. J Clin Oncol. 2018 Sep 20;36(27):2796-2803. doi: 10.1200/JCO.2018.79.1483. Epub 2018 Aug 8.

    PMID: 30089078BACKGROUND
  • 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.

    PMID: 35245446BACKGROUND
  • 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.

    PMID: 35440464BACKGROUND
  • 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.

    PMID: 19732130BACKGROUND
  • Chen Y, Ye J, Zhu Z, Zhao W, Zhou J, Wu C, Tang H, Fan M, Li L, Lin Q, Xia Y, Li Y, Li J, Jia H, Lu S, Zhang Z, Zhao K. Comparing Paclitaxel Plus Fluorouracil Versus Cisplatin Plus Fluorouracil in Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Cancer: A Randomized, Multicenter, Phase III Clinical Trial. J Clin Oncol. 2019 Jul 10;37(20):1695-1703. doi: 10.1200/JCO.18.02122. Epub 2019 Mar 28.

    PMID: 30920880BACKGROUND
  • Lockhart AC, Reed CE, Decker PA, Meyers BF, Ferguson MK, Oeltjen AR, Putnam JB, Cassiv SD, Montero AJ, Schefter TE. Phase II study of neoadjuvant therapy with docetaxel, cisplatin, panitumumab, and radiation therapy followed by surgery in patients with locally advanced adenocarcinoma of the distal esophagus (ACOSOG Z4051). Ann Oncol. 2019 Feb 1;30(2):345. doi: 10.1093/annonc/mdx813. No abstract available.

    PMID: 29390067BACKGROUND
  • 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.

    PMID: 33891478BACKGROUND
  • 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.

    PMID: 34160577BACKGROUND
  • 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.

    PMID: 22552194BACKGROUND
  • 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.

    PMID: 39808888BACKGROUND
  • Filho AM, Laversanne M, Ferlay J, Colombet M, Pineros M, Znaor A, Parkin DM, Soerjomataram I, Bray F. The GLOBOCAN 2022 cancer estimates: Data sources, methods, and a snapshot of the cancer burden worldwide. Int J Cancer. 2025 Apr 1;156(7):1336-1346. doi: 10.1002/ijc.35278. Epub 2024 Dec 17.

    PMID: 39688499BACKGROUND

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

RadiotherapyImmunotherapySurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsImmunomodulationBiological Therapy

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2025

First Posted

May 7, 2025

Study Start

April 15, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations