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

Recruiting

• Conditions: Chemoradiotherapy; Initial Inoperable; Esophageal Squamous Cell Carcinoma
• Interventions: Other: regular chemoradiotherapy

• Registration Number: NCT06190847
• Lead Sponsor: Anhui Provincial Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-01
• Status Verified: 2023-12
• Study First Submitted: 2023-12-20
• Study First Submitted QC: 2023-12-20
• Last Update Submitted: 2023-12-20
• Study First Posted: 2024-01-05
• Last Update Posted: 2024-01-05
• Primary Completion: 2026-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 97

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental	regular chemoradiotherapy	cancer

Primary Outcome Measures

Name	Time	Method
pCR	1 month post treatment

Secondary Outcome Measures

Name	Time	Method
the surgical conversion rate	1month post treatment
EFS	1 to 3 years

Trial Locations

Locations (1)

Dong Qian; 🇨🇳 Hefei, Anhui, China