Oral Microbiome is Associated With the Response to Chemoradiotherapy in Initial Inoperable Patients With Esophageal Squamous Cell Cancer

December 20, 2023 updated by: Dong Qian, Anhui Provincial Hospital
Esophageal cancer accounts for more than half of the world, seriously affecting people's health in China. 95% patients are squamous cell carcinoma. Surgery is the preferred treatment for early and middle stage esophageal cancer, but patients with clinical stage T4b or other surgical contraindications have no surgical opportunity. In recent years, radical chemoradiotherapy has played a key role in the treatment of local advanced esophageal cancer with some poor predicting biomarkers. Oral bacteria may play a pathogenic role in cancer and other chronic diseases by producing chemical carcinogens and inflammatory factors through direct metabolism. A large number of studies have also suggested that tooth loss and poor oral hygiene are closely related to upper digestive tract cancer, indicating the possible role of oral microorganisms in the occurrence and development of upper digestive tract cancer, and saliva is the main source of oral flora colonization. Therefore, it is worth further research to explore the interaction between microbial metabolism imbalance and radiotherapy in patients with esophageal cancer. In summary, we intend to conduct a prospective cohort study to explore the role of salivary microbes in radiotherapy in patients with initially inoperable patients with local advanced esophageal cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

97

Contacts and Locations

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

Study Locations

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

Yes

Sampling Method

Non-Probability Sample

Study Population

initial inoperable esophageal squamous cell carcinoma

Description

Inclusion Criteria:

  • 18-85 years old;

    • Eastern Cooperative Oncology Group (ECOG) 0-2;
    • Esophageal squamous cell carcinoma;
    • cT2-4aN0-3M0 (AJCC 8th) confirmed by radiological examination;
    • initial unresectable at initial diagnosis confirmed by thoracic surgeons;
    • Treatment naive;
    • No contraindications for adjuvant chemoradiotherapy;
    • Signature of inform consent.

Exclusion Criteria:

  • • younger than 18 years old or older than 85 years old;

    • ECOG>2;
    • Esophageal adenocarcinoma, small-cell cancer and other pathological types;
    • cT1anyNM0, cT4banyNM0, c anyTanyNM0 confirmed by radiological examination;
    • Resectable at initial diagnosis confirmed by thoracic surgeons;
    • Previous treatment of chemotherapy, radiotherapy, and other treatment;
    • Contraindications for chemoradiotherapy;
    • No signature of inform consent.

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
Experimental
cancer
Other: regular chemoradiotherapy
regular chemoradiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pCR
Time Frame: 1 month post treatment
1 month post treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
EFS
Time Frame: 1 to 3 years
1 to 3 years
the surgical conversion rate
Time Frame: 1month post treatment
1month post treatment

Collaborators and Investigators

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

Sponsor

Anhui Provincial Hospital

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)

July 1, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

December 20, 2023

First Submitted That Met QC Criteria

December 20, 2023

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

December 20, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-KY202

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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