Actively Recruiting
Prospective Cohort Study on Oral Microbiome Changes in Patients With Locally Advanced Oral Squamous Cell Carcinoma Following Neoadjuvant Chemoimmunotherapy
Led by Zhujiang Hospital · Updated on 2025-09-23
32
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how changes in the oral microbiome relate to tumor markers in patients with locally advanced oral squamous cell carcinoma (LA-OSCC) after receiving neoadjuvant chemoimmunotherapy. This study aims to understand the implications of these changes for treatment effectiveness, resistance to chemotherapy, and predicting patient outcomes. The study is observational and sponsored by Zhujiang Hospital. Participants will receive two cycles of intravenous neoadjuvant treatment consisting of Tislelizumab (200 mg) every three weeks, combined with chemotherapy drugs Paclitaxel, Cisplatin, or Carboplatin administered intravenously during each three-week cycle. This treatment schedule is planned for two cycles before further evaluation. During the study, participants will be monitored for their response to treatment at eight weeks using the Objective Response Rate. Researchers will also track longer-term outcomes including overall survival and progression-free survival over two years. Assessments will include blood tests and evaluations of organ function to ensure participants can tolerate treatment. The total study duration extends through follow-up periods up to two years to assess treatment impact and prognosis.
CONDITIONS
Brief Title
Prospective Cohort Study on Oral Microbiome Changes in Patients With Locally Advanced Oral Squamous Cell Carcinoma Following Neoadjuvant Chemoimmunotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Oral squamous cell carcinoma diagnosed as locally advanced according to AJCC staging.
- Age between 18 and 80 years, any gender.
- No prior head and neck radiation therapy or chemotherapy.
- Adequate blood function: WBC 3.5 x 10^9/L, PLT 75 x 10^9/L, HGB 90 g/L.
- Adequate liver function: TBIL upper limit of normal, AST and ALT 2.5 times upper limit.
- Adequate renal function: eGFR > 45 mL/min/1.73 m8.
- Vital organ function and general condition tolerate neoadjuvant chemoimmunotherapy.
- Performance status score = 2.
- Signed informed consent and voluntarily agree to participate.
You will not qualify if you...
- Pregnancy or lactation (for females).
- History of epilepsy or uncontrolled psychiatric disorders.
- Severe allergic conditions or suspected/confirmed alcohol or drug addiction.
- Use of antibiotics within 7 days before enrollment.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 6 weeks
Participants receive 2 cycles of intravenous neoadjuvant Tislelizumab and chemotherapy every 3 weeks.
2 treatment visits every 3 weeks
Duration - 24 months
Participants are monitored for outcomes including survival and disease progression over two years following treatment.
Regular visits during the 24-month follow-up period
Trial Site Locations
Total: 1 location
1
Department of Stomatology, Zhujiang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
X
Xiaozhi LV
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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