Predicting Postoperative Chemotherapy Efficacy in Patients With Esophageal Squamous Cell Carcinoma

City of Hope

Status: Enrolling

Conditions: DNA Methylation; Chemotherapy Effect; Esophageal Squamous Cell Carcinoma

Treatments: Drug: Fluoro Uracil

Study type: Observational

Funder types: Other

Identifiers

NCT06490003

23228/ESCC-Chemo

Details and patient eligibility

About

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.

Full 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

Enrollment: 150 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

150 participants in 2 patient groups

Chemotherapy response patients.

Description:

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)

Treatment:

Drug: Fluoro Uracil

Chemotherapy non-response patients

Description:

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)

Treatment:

Drug: Fluoro Uracil