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

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06190847
• Other study ID #: 2023-KY202
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: July 1, 2026

Study information

• Verified date: December 2023
• Source: Anhui Provincial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 97
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Chemoradiotherapy
• Esophageal Squamous Cell Carcinoma
• Neoplasms, Squamous Cell

Intervention

Other:
• regular chemoradiotherapy
regular chemoradiotherapy

Locations

Country	Name	City	State
China	Dong Qian	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Anhui Provincial Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pCR		1 month post treatment
Secondary	EFS		1 to 3 years
Secondary	the surgical conversion rate		1month post treatment