RecruitingNCT06190847

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


Sponsor

Anhui Provincial Hospital

Enrollment

97 participants

Start Date

Jul 1, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting oral microbiome samples (bacteria in the mouth) from patients with advanced esophageal squamous cell cancer to see if the type of bacteria present predicts how well chemotherapy and radiation will work. **You may be eligible if...** - You are between 18 and 85 years old with good performance status (ECOG 0–2) - You have esophageal squamous cell carcinoma that was not surgically removable at the time of diagnosis - You have not received any prior cancer treatment - Your cancer is confirmed to be locally advanced (specific stage criteria) **You may NOT be eligible if...** - You have esophageal adenocarcinoma or other non-squamous cell cancer types - Your cancer is either very early stage or has spread to the extent that surgery is an option - You cannot safely receive chemoradiotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERregular chemoradiotherapy

regular chemoradiotherapy


Locations(1)

Dong Qian

Hefei, Anhui, China

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NCT06190847


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