Actively Recruiting
The Combination of Adebrelimab and TP Regimen for Neoadjuvant Therapy in Patients With Stage IVB Oral Squamous Cell Carcinoma
Led by Hospital of Stomatology, Wuhan University · Updated on 2025-05-29
35
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this \[type of study:clinical trial\] is to \[learn about\] in \[Clinical IVB stage oral squamous cell carcinoma patients\]. The main question it aims to answer are: • \[Observing the effectiveness and safety of the combination of Adebrelimab and TP regimen in neoadjuvant therapy for clinical IVB stage oral squamous cell carcinoma patients\] Participants will \[Received treatment with Adebrelimab combined with TP regimen, followed by surgery after 2 cycles of neoadjuvant therapy. After surgery, radiotherapy and chemotherapy combined with immunotherapy were chosen based on the patient\'s condition, with a total follow-up of two years.\].
CONDITIONS
Official Title
The Combination of Adebrelimab and TP Regimen for Neoadjuvant Therapy in Patients With Stage IVB Oral Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with oral squamous cell carcinoma by histology or cytology
- No previous treatment for oral squamous cell carcinoma
- Clinical stage IVB according to AJCC TNM system
- ECOG performance status of 0 or 1
- Expected survival time of at least 12 weeks
- Adequate organ function based on laboratory tests: neutrophil count ≥ 1.5 x 10^9/L, platelet count ≥ 100 x 10^9/L, hemoglobin ≥ 90 g/L; liver function within specified limits; renal function with creatinine clearance ≥ 60 ml/min/1.73 m2
- Use medically recognized contraception during treatment and for 6 months after last treatment if fertile
- Willingness to participate, sign informed consent, and comply with follow-up
You will not qualify if you...
- Uncontrollable pleural, pericardial, or abdominal effusions requiring repeated drainage
- Allergy history to components of Adebrelimab
- Prior investigational drug use within 4 weeks or half-life not expired
- Participation in other interventional clinical trials
- Anti-tumor therapy within 2 weeks before study drug
- Use of corticosteroids above 10mg prednisone equivalent within 2 weeks before study drug (with exceptions)
- Receipt of anti-tumor or live vaccines within 4 weeks before study drug
- Major surgery or severe trauma within 4 weeks before study drug
- Previous treatment with paclitaxel drugs
- Unresolved toxicity from prior anti-tumor treatments above specified levels
- History of active autoimmune diseases (with some exceptions)
- Immune deficiency or history of organ/bone marrow transplantation
- Uncontrolled cardiovascular conditions
- Serious infections within 4 weeks before study drug
- History of interstitial lung disease excluding certain types
- Active or recent pulmonary tuberculosis
- Other malignancies within 5 years except low-risk tumors
- Pregnant or breastfeeding women
- Other conditions judged by researchers to affect safety or study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
School of Stomatology Wuhan University
Hubei, Wuhan, China, 430079
Actively Recruiting
Research Team
J
JJia Associate Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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