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Esophageal Squamous Cell CarcinomaNCT06490003

Predicting Postoperative Chemotherapy Efficacy in Patients With Esophageal Squamous Cell Carcinoma

An observational study of Esophageal Squamous Cell Carcinoma and Chemotherapy Effect, run by City of Hope Medical Center at 1 site in Japan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Esophageal cancer remains a disease with a poor prognosis. Chemotherapy is an important part of its treatment, but there are cases in which chemotherapy is ineffective. The investigators aim to develop a model to predict the response to chemotherapy by DNA methylation of preoperative biopsy specimens to identify the… Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Fluoro Uracil
How many people
150 participants
Where
1 siteJapan
Study dates
1 Jun 2004to 18 Jun 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Chemotherapy naive patient needed esophageal squamous cell carcinoma chemotherapy

Who may be able to join

  • Patients who had histologically confirmed esophageal squamous cell carcinoma.
  • Patients who had undergone chemotherapy.
  • Patients receiving initial chemotherapy
  • Written informed consent following full study information is provided to the patient.

Who cannot join

  • Patients for whom a preoperative biopsy sample cannot be obtained
  • Patients who cannot assess at 2 months later after chemotherapy.
  • Patients with multiple cancers.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ajay Goel, PhD contact

6262183452

AJGOEL@COH.ORG

Koichi Takiguchi, PhD contact

6262183452

ktakiguchi@coh.org

Japan1 site, 1 recruiting

  • Yamanashi Universiy

    Chūō, Yamanashi, 4093898

    Katsutoshi Shoda, PhD, kshoda@yamanashi.ac.jp

    Recruiting

Other trials in Japan

About this study

Official title: Predicting Postoperative Chemotherapy Efficacy in Patients With Esophageal Squamous Cell Carcinoma by Biopsy Specimens.

Esophageal cancer remains a disease with a poor prognosis. Chemotherapy is an important part of its treatment, but there are cases in which chemotherapy is ineffective. The investigators aim to develop a model to predict the response to chemotherapy by DNA methylation of preoperative biopsy specimens to identify the chemotherapy ineffective group.

Read the detailed description

Esophageal cancer remains a disease with a poor prognosis. In the treatment of esophageal squamous cell carcinoma (ESCC), multidisciplinary treatment including surgery, chemotherapy, and radiation therapy is important. Chemotherapy is an effective treatment for esophageal cancer, but some patients do not respond to it. Non-response to chemotherapy can result in disease progression, loss of patient fitness, and even the opportunity to receive other treatments that might have originally had a therapeutic effect. If there are biomarkers that could indicate the efficacy of chemotherapy before treatment, ineffective patients would be able to change their treatment plan. Patients on preoperative chemotherapy would be able to avoid unnecessary chemotherapy and undergo surgery without the effects of physical weakness and side effects. On the other hand, patients on definitive chemotherapy may choose to intensify their treatment with additional radiation therapy or immunotherapy. The investigators aim to develop a model to predict the response to chemotherapy by DNA methylation of preoperative biopsy specimens to identify the chemotherapy ineffective

Being tested
Fluoro Uracil
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fluoro UracilDrug

    Also called Cisplatin

    Esophageal cancer chemotherapy（First line treatment)

Study groups in NCT06490003
Study groupRoleWhat they receive
Chemotherapy response patients.Responders according to the response evaluation criteria in solid tumors (RECIST). A panel of DNA methylation, whose specific methylation level is tested DNA from resection tissue with Methylation-specific PCR(MSP)
Receives: Drug: Fluoro Uracil
Chemotherapy non-response patientsResponders according to the response evaluation criteria in solid tumors (RECIST). A panel of DNA methylation, whose specific methylation level is tested DNA from resection tissue with Methylation-specific PCR(MSP)
Receives: Drug: Fluoro Uracil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate(Chemotherapy)

    The effect of initial chemotherapy is evaluated by imaging. Response evaluation criteria in solid tumors (RECIST) is used for treatment efficacy.

    Measured: 1year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2024
  2. Study start1 Jun 2004
  3. Primary completion18 Jun 2028 (estimated)
  4. Study completion18 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06490003
Sponsor's protocol ID
23228/ESCC-Chemo
Status last verified
Jul 2026
First submitted
21 Jun 2024
Last updated
13 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.

    PubMed 38572751

  • Morgan E, Soerjomataram I, Rumgay H, Coleman HG, Thrift AP, Vignat J, Laversanne M, Ferlay J, Arnold M. The Global Landscape of Esophageal Squamous Cell Carcinoma and Esophageal Adenocarcinoma Incidence and Mortality in 2020 and Projections to 2040: New Estimates From GLOBOCAN 2020. Gastroenterology. 2022 Sep;163(3):649-658.e2. doi: 10.1053/j.gastro.2022.05.054. Epub 2022 Jun 4.

    PubMed 35671803

  • Shah MA, Kennedy EB, Catenacci DV, Deighton DC, Goodman KA, Malhotra NK, Willett C, Stiles B, Sharma P, Tang L, Wijnhoven BPL, Hofstetter WL. Treatment of Locally Advanced Esophageal Carcinoma: ASCO Guideline. J Clin Oncol. 2020 Aug 10;38(23):2677-2694. doi: 10.1200/JCO.20.00866. Epub 2020 Jun 22.

    PubMed 32568633

  • Macedo-Silva C, Constancio V, Miranda-Goncalves V, Leite-Silva P, Salta S, Lobo J, Guimaraes R, Carvalho-Maia C, Gigliano D, Farinha M, Sousa O, Henrique R, Jeronimo C. DNA methylation biomarkers accurately detect esophageal cancer prior and post neoadjuvant chemoradiation. Cancer Med. 2023 Apr;12(7):8777-8788. doi: 10.1002/cam4.5623. Epub 2023 Jan 20.

    PubMed 36670548

  • Zhang Y, Cao Y, Zhang J, Huang M, Roy P, Huang B, Yang H, Rong Y, Chen Y, Zhu C, Fang W, Yu Z, Mao W, Xiang J, Han Y, Lin J, Zhang J, Fu J, He J, Li H. Lymph Node Ratio Improves Prediction of Overall Survival in Esophageal Cancer Patients Receiving Neoadjuvant Chemoradiotherapy: A National Cancer Database Analysis. Ann Surg. 2023 Jun 1;277(6):e1239-e1246. doi: 10.1097/SLA.0000000000005450. Epub 2022 Jul 6.

    PubMed 35797545

  • Zhang XY, Yan WP, Sun Y, Li XT, Chen Y, Fan MY, Wu Y, Liang Z, Xiong HC, Wang ZL, Sun YS, Chen KN. CT Signs Can Predict Treatment Response and Long-Term Survival: A Study in Locally Advanced Esophageal Cancer with Preoperative Chemotherapy. Ann Surg Oncol. 2015 Dec;22 Suppl 3:S1380-7. doi: 10.1245/s10434-015-4531-2. Epub 2015 May 5.

    PubMed 25940570

  • Oliver J, Garcia-Aranda M, Chaves P, Alba E, Cobo-Dols M, Onieva JL, Barragan I. Emerging noninvasive methylation biomarkers of cancer prognosis and drug response prediction. Semin Cancer Biol. 2022 Aug;83:584-595. doi: 10.1016/j.semcancer.2021.03.012. Epub 2021 Mar 20.

    PubMed 33757849

  • Komoto S, Noma K, Kato T, Kobayashi T, Nishiwaki N, Narusaka T, Sato H, Katsura Y, Kashima H, Kikuchi S, Ohara T, Tazawa H, Fujiwara T. Conventional Cancer Therapies Can Accelerate Malignant Potential of Cancer Cells by Activating Cancer-Associated Fibroblasts in Esophageal Cancer Models. Cancers (Basel). 2023 May 30;15(11):2971. doi: 10.3390/cancers15112971.

    PubMed 37296933

  • Jeong DY, Lee KS, Choi JY, Chung MJ, Min YW, Kim HK, Zo JI, Shim YM, Sun JM. Surgically Resected Esophageal Squamous Cell Carcinoma: Patient Survival and Clinicopathological Prognostic Factors. Sci Rep. 2020 Mar 19;10(1):5077. doi: 10.1038/s41598-020-62028-5.

    PubMed 32193500

  • Cao W, Lee H, Wu W, Zaman A, McCorkle S, Yan M, Chen J, Xing Q, Sinnott-Armstrong N, Xu H, Sailani MR, Tang W, Cui Y, Liu J, Guan H, Lv P, Sun X, Sun L, Han P, Lou Y, Chang J, Wang J, Gao Y, Guo J, Schenk G, Shain AH, Biddle FG, Collisson E, Snyder M, Bivona TG. Multi-faceted epigenetic dysregulation of gene expression promotes esophageal squamous cell carcinoma. Nat Commun. 2020 Jul 22;11(1):3675. doi: 10.1038/s41467-020-17227-z.

    PubMed 32699215

  • Liu Z, Zhao Y, Kong P, Liu Y, Huang J, Xu E, Wei W, Li G, Cheng X, Xue L, Li Y, Chen H, Wei S, Sun R, Cui H, Meng Y, Liu M, Li Y, Feng R, Yu X, Zhu R, Wu Y, Li L, Yang B, Ma Y, Wang J, Zhu W, Deng D, Xi Y, Wang F, Li H, Guo S, Zhuang X, Wang X, Jiao Y, Cui Y, Zhan Q. Integrated multi-omics profiling yields a clinically relevant molecular classification for esophageal squamous cell carcinoma. Cancer Cell. 2023 Jan 9;41(1):181-195.e9. doi: 10.1016/j.ccell.2022.12.004. Epub 2022 Dec 29.

    PubMed 36584672

Questions about this trial

What is this clinical trial studying?

An observational study of Esophageal Squamous Cell Carcinoma and Chemotherapy Effect, run by City of Hope Medical Center at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ajay Goel, PhD (6262183452, AJGOEL@COH.ORG), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate(Chemotherapy) (time frame: 1year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06490003, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.

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