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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06190847
Enrollment
97
Registered
2024-01-05
Start date
2023-07-01
Completion date
2026-07-01
Last updated
2024-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemoradiotherapy, Esophageal Squamous Cell Carcinoma, Initial Inoperable

Brief 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.

Interventions

OTHERregular chemoradiotherapy

regular chemoradiotherapy

Sponsors

Anhui Provincial Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
pCR1 month post treatment

Secondary

MeasureTime frame
EFS1 to 3 years
the surgical conversion rate1month post treatment

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026