Predicting Postoperative Chemotherapy Efficacy in Patients With Esophageal Squamous Cell Carcinoma

NCT ID: NCT06490003

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-06-01
• Study Completion Date: 2026-06-18

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.

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

Conditions

Esophageal Squamous Cell Carcinoma; Chemotherapy Effect; DNA Methylation

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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)

Fluoro Uracil

Intervention Type: DRUG

Esophageal cancer chemotherapy（First line treatment)

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)

Fluoro Uracil

Intervention Type: DRUG

Esophageal cancer chemotherapy（First line treatment)

Interventions

Fluoro Uracil

Esophageal cancer chemotherapy（First line treatment)

Intervention Type: DRUG

Other Intervention Names

Cisplatin

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

City of Hope Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Koichi Takiguchi, PhD

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

Yamanashi Universiy

Chūō, Yamanashi, Japan

Site Status: RECRUITING

Countries

Japan

Central Contacts

Ajay Goel, PhD

Role: CONTACT

AJGOEL@COH.ORG

6262183452

Koichi Takiguchi, PhD

Role: CONTACT

ktakiguchi@coh.org

6262183452

Facility Contacts

Katsutoshi Shoda, PhD

Role: primary

kshoda@yamanashi.ac.jp

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Other Identifiers

23228/ESCC-Chemo

Identifier Type: -

Identifier Source: org_study_id