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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorAnhui Provincial Hospital

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

18-85 years old;

Eastern Cooperative Oncology Group (ECOG) 0-2;

Esophageal squamous cell carcinoma;

cT2-4aN0-3M0 (AJCC 8th) confirmed by radiological examination;

Disqualifiers

• 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;

Trial population

initial inoperable esophageal squamous cell carcinoma

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • regular chemoradiotherapy

    Other intervention

    regular chemoradiotherapy

Treatment groups

97 Participants
are divided into 1 treatment group
Group A: Experimental1 intervention

Trial outcomes

Primary outcomes

1

pCR

Time frame
1 month post treatment

Secondary outcomes

1

EFS

Time frame
1 to 3 years
2

the surgical conversion rate

Time frame
1month post treatment

Other outcomes

Sponsors and contacts

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