Clinical trial NCT06190847: Oral Microbiome is Associated With the Response to Chemoradiotherapy in Initial Inoperable Patients With Esophageal Squamous Cell Cancer
Official title: Oral Microbiome is Associated With the Response to Chemoradiotherapy in Initial Inoperable Patients With Esophageal Squamous Cell Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophageal Squamous Cell Carcinoma
Chemoradiotherapy
Initial Inoperable
Lead sponsor: Anhui Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2024-01-05
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: initial inoperable esophageal squamous cell carcinoma

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.


Eligibility criteria: 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.

Primary outcomes:
measure: pCR
timeFrame: 1 month post treatment
Secondary outcomes:
measure: EFS
timeFrame: 1 to 3 years
measure: the surgical conversion rate
timeFrame: 1month post treatment
Other outcomes:
Locations:
city: Hefei
country: China
facility: Dong Qian
state: Anhui
Study officials:
References: