Predicting Postoperative Chemotherapy Efficacy in Patients With Esophageal Squamous Cell Carcinoma

July 9, 2025 updated by: City of Hope Medical Center

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Japan
    • Yamanashi
      • Chuo, Yamanashi, Japan, 4093898

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Chemotherapy naive patient needed esophageal squamous cell carcinoma chemotherapy

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Esophageal cancer chemotherapy（First line treatment)
Other Names:
  • Cisplatin
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
Esophageal cancer chemotherapy（First line treatment)
Other Names:
  • Cisplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate(Chemotherapy)
Time Frame: 1year
The effect of initial chemotherapy is evaluated by imaging. Response evaluation criteria in solid tumors (RECIST) is used for treatment efficacy.
1year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City of Hope Medical Center

Investigators

  • Principal Investigator: Koichi Takiguchi, PhD, City of Hope Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2004

Primary Completion (Estimated)

June 18, 2026

Study Completion (Estimated)

June 18, 2026

Study Registration Dates

First Submitted

June 21, 2024

First Submitted That Met QC Criteria

July 3, 2024

First Posted (Actual)

July 8, 2024

Study Record Updates

Last Update Posted (Actual)

July 11, 2025

Last Update Submitted That Met QC Criteria

July 9, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23228/ESCC-Chemo

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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