Clinical trial NCT06960889: A Retrospective Clinical Study Exploring Prognostic Factors in Esophageal Cancer Patients
Official title: A Retrospective Clinical Study Exploring Prognostic Factors in Esophageal Cancer Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Esophageal Cancer (EsC)
Keywords: Prognostic factors
Treatment strategies
Efficacy comparison
Esophageal cancer
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2025-05-07
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Esophageal Cancer Patients

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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: From the date of treatment initiation to the date of death from any cause,assessed up to 120 months.
Secondary outcomes:
measure: Pathologic Complete Response ( pCR )
timeFrame: Perioperative
measure: Major Pathological Response Rate (MPR)
timeFrame: Perioperative
measure: Progression-Free Survival (PFS)
timeFrame: From treatment initiation to disease progression or death, assessed up to 100 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangzhou
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.