Predicting Postoperative Chemotherapy Efficacy in Patients With Esophageal Squamous Cell Carcinoma

NCT06490003 | Recruiting

• 1 other identifier: 23228/ESCC-Chemo
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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 chemotherapy ineffective group.

Conditions

Esophageal Squamous Cell Carcinoma; Chemotherapy Effect; DNA Methylation

Outcome Measures

Primary Outcomes (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.

  1year

Study Arms (2)

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)

Drug: Fluoro Uracil

Chemotherapy non-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)

Drug: Fluoro Uracil

Interventions

Fluoro Uracil DRUG

Esophageal cancer chemotherapy（First line treatment)

Also known as: Cisplatin

Chemotherapy non-response patients; Chemotherapy response patients.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chemotherapy naive patient needed esophageal squamous cell carcinoma chemotherapy

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• City of Hope Medical Center: lead

Study Sites (1)

Yamanashi Universiy

Chūō, Yamanashi, 4093898, Japan

RECRUITING

Related Publications (11)

• 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.

  PMID: 38572751 BACKGROUND

• 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.

  PMID: 35671803 BACKGROUND

• 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.

  PMID: 32568633 BACKGROUND

• 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.

  PMID: 36670548 BACKGROUND

• 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.

  PMID: 35797545 BACKGROUND

• 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.

  PMID: 25940570 BACKGROUND

• 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.

  PMID: 33757849 BACKGROUND

• 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.

  PMID: 37296933 BACKGROUND

• 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.

  PMID: 32193500 BACKGROUND

• 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.

  PMID: 32699215 BACKGROUND

• 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.

  PMID: 36584672 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Formalin-fixed and paraffin-embedded (FFPE) samples derived from biopsy specimens

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Fluorouracil; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Koichi Takiguchi, PhD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ajay Goel, PhD

CONTACT

6262183452; AJGOEL@COH.ORG

Koichi Takiguchi, PhD

CONTACT

6262183452; ktakiguchi@coh.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: July 8, 2024
• Study Start: June 1, 2004
• Primary Completion (Estimated): June 18, 2026
• Study Completion (Estimated): June 18, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-07

Locations

JP (1)