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

NCT06190847 — Unknown, 97 participants, Anhui Provincial Hospital

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RegistryNCT06190847
StatusUnknown
Study typeObservational
Enrollment97 (Estimated)
SponsorAnhui Provincial Hospital (Other gov)
ConditionsEsophageal Squamous Cell Carcinoma, Chemoradiotherapy, Initial Inoperable
Interventionsregular chemoradiotherapy (Other)
Datesstart 2023-07-01, primary completion 2026-07-01 (estimated), completion 2026-07-01 (estimated), first posted 2024-01-05, last updated 2024-01-05
Locations1 site in China

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
ExperimentalOther: regular chemoradiotherapycancer
  • regular chemoradiotherapy (Other): regular chemoradiotherapy

+Outcome measures

Primary outcomes

  • pCR [1 month post treatment]

Secondary outcomes

  • EFS [1 to 3 years]
  • the surgical conversion rate [1month post treatment]

+Eligibility

Sex: All, ages: 18 Years to 85 Years, accepts healthy volunteers

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.

+Locations (1)

FacilityCityCountryStatus
Dong QianHefei, AnhuiChinaRecruiting

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