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

NCT06190847 | Recruiting DMC

• 1 other identifier: 2023-KY202
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Squamous Cell Carcinoma; Chemoradiotherapy; Initial Inoperable

Outcome Measures

Primary Outcomes (1)

• pCR

  1 month post treatment

Secondary Outcomes (2)

• EFS

  1 to 3 years

• the surgical conversion rate

  1month post treatment

Study Arms (1)

Experimental

cancer

Other: regular chemoradiotherapy

Interventions

regular chemoradiotherapy OTHER

regular chemoradiotherapy

Experimental

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

initial inoperable esophageal squamous cell carcinoma

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

Study Sites (1)

Dong Qian

Hefei, Anhui, 230001, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 5, 2024
• Study Start: July 1, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 5, 2024

Record last verified: 2023-12

Locations

CN (1)