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NCT Number: NCT06490003

Predicting Postoperative Chemotherapy Efficacy in Patients With Esophageal Squamous Cell Carcinoma

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Fluoro Uracil

Drug

Esophageal cancer chemotherapy(First line treatment)

Other names: Cisplatin

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ajay Goel, PhD

CONTACT

[email protected]

6262183452

Koichi Takiguchi, PhD

CONTACT

[email protected]

6262183452

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2028
Study completion
2028
First posted
Jul 8, 2024
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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