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Active, not recruitingNCT06960889Updated Apr 14, 2026

A Retrospective Clinical Study Exploring Prognostic Factors in Esophageal Cancer Patients

An observational study in Esophageal Cancer (EsC), sponsored by Nanfang Hospital, Southern Medical University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-04-14.

Sponsored by Nanfang Hospital, Southern Medical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
500
Ages
18 Years to 90 Years
Sex
All
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Study 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.

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Conditions studied

  • Esophageal Cancer (EsC)

Keywords

  • Prognostic factors
  • Treatment strategies
  • Efficacy comparison
  • Esophageal cancer
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In context

Esophageal Neoplasms

1,593 studies on the registry are indexed under Esophageal Neoplasms; 460 are open to participants now.

This study's planned enrollment of 500 is above the median of 200 across 340 observational studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

Nanfang Hospital, Southern Medical University is the lead sponsor of 480 studies on the registry; 212 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Esophageal Cancer Patients

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Otherradiotherapy

    Definitive radiotherapy or radiotherapy-based combined modality therapy

  • DrugImmunotherapy

    Immune checkpoint inhibitors as monotherapy or in combination with other therapies

  • Proceduresurgery (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

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What researchers measure

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.

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

Secondary outcomes

  1. Pathologic Complete Response ( pCR )

    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.

    Time frame: Perioperative

  2. Major Pathological Response Rate (MPR)

    The proportion of patients with ≤10% residual viable tumor cells in resected specimens

    Time frame: Perioperative

  3. Progression-Free Survival (PFS)

    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.

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

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Study locations

1 site
  • Nanfang Hospital, Southern Medical University
    Guangzhou, Guangzhou 510515, China
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References and documents

Publications

  • 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. PubMed 39713872 ↗
  • 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. PubMed 32760099 ↗
  • 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. PubMed 40061941 ↗
  • 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. PubMed 30089078 ↗
  • 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. PubMed 35245446 ↗
  • 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. PubMed 35440464 ↗
  • 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. PubMed 19732130 ↗
  • 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. PubMed 30920880 ↗
  • 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. PubMed 29390067 ↗
  • 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. PubMed 33891478 ↗
  • 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. PubMed 34160577 ↗
  • 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. PubMed 22552194 ↗
  • 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. PubMed 39808888 ↗
  • 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. PubMed 39688499 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06960889
Lead sponsor
Nanfang Hospital, Southern Medical University
Responsible party
Sponsor
First posted
May 7, 2025
Start date
Apr 15, 2025
Primary completion
Dec 31, 2026 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Apr 14, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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