Exploring the link between oral bacteria and treatment response in esophageal cancer patients
Oral Microbiome is Associated With the Response to Chemoradiotherapy in Initial Inoperable Patients With Esophageal Squamous Cell Cancer
This study is testing if the types of bacteria in the mouth can help predict how well chemotherapy and radiation work for patients with inoperable esophageal cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 97 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Anhui Provincial Hospital Government |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hefei, Anhui) |
| Trial ID | NCT06190847 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between the oral microbiome and the effectiveness of chemoradiotherapy in patients with initial inoperable esophageal squamous cell carcinoma. It focuses on patients who are treatment naive and have specific clinical characteristics that make them unsuitable for surgery. By analyzing the oral bacteria present in these patients, the study aims to identify potential biomarkers that could predict treatment outcomes. The findings may provide insights into how oral health impacts cancer treatment responses.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-85 with initial unresectable esophageal squamous cell carcinoma who have not received prior treatment.
Not a fit: Patients with other types of esophageal cancer, those who are resectable at diagnosis, or those with contraindications for chemoradiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with esophageal cancer by identifying oral microbiome factors that influence chemoradiotherapy effectiveness.
How similar studies have performed: While the role of the oral microbiome in cancer treatment is an emerging field, this specific approach has not been extensively tested in similar studies, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hefei, Anhui
- Dong Qian — Hefei, Anhui, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.