Prospective Cohort Study on Oral Microbiome Changes in Patients With Locally Advanced Oral Squamous Cell Carcinoma Following Neoadjuvant Chemoimmunotherapy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorZhujiang Hospital

About this trial

Investigating the Relationship Between Oral Microbiome Alterations and Tumor Markers in Locally Advanced Oral Squamous Cell Carcinoma (LA-OSCC) After Neoadjuvant Chemoimmunotherapy: Implications for Therapeutic Efficacy, Chemoresistance, and Prognostic Assessment

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Oral squamous cell carcinoma (OSCC) diagnosed as locally advanced (T3N0M0, T1-3N1M0, T4aN0-2M0, T1-4aN3M0, or T4bN0-3M0) according to AJCC staging criteria.

Their age ranged from 18 to 80 years;regardless of gender.

Absence of prior head and neck radiation therapy or chemotherapy.

Adequate blood function: white blood cell count (WBC) >=3.5×10^9/L, platelet count (PLT) >=75×10^9/L:Hemoglobin concentration (HGB) >=90g/L.

Disqualifiers

Pregnancy or lactation (for female participants).

Patients with a history of epilepsy or psychiatric disorders that were not well-controlled.

Patients with severe allergic diathesis or suspected or confirmed alcohol or drug addiction.

Patients who had taken antibiotics within 7 days before enrollment.

Trial population

Patients with locally advanced oral squamous cell carcinoma (OSCC) attending the Department of Stomatology, Zhujiang Hospital.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

32 Participants
are grouped into 1 trial group
Group A: Exposed Group

Trial outcomes

Primary outcomes

1

Objective Response Rate

According to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, it is defined as the proportion of patients who achieved Complete Response (CR) or Partial Response (PR).Complete Response (CR) was defined as disappearance of all target lesions. Partial Response (PR) was defined as \>=30% decrease in the sum of the longest diameter of target lesions.

Time frame
8 weeks

Secondary outcomes

1

two-year overall survival rate

The proportion of patients surviving ≥2 years post-treatment

Time frame
24 months
2

two-year progression-free survival rate

The proportion of patients who remain alive and progression-free for 2 years after treatment

Time frame
24 months

Other outcomes

Sponsors and contacts

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