Actively Recruiting
Neoadjuvant Treatment of Tislelizumab Combined Chemotherapy for Locally Advanced Oral Squamous Cell Carcinoma ：A Single-arm, Prospective, Phase II Trial
Led by Weijia Fang, MD · Updated on 2023-07-17
30
Participants Needed
1
Research Sites
268 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
TPF is still recommended as the preferred induction chemotherapy regimen for nonsurgical treatment of patients with LA HNSCC. Based on the KEYNOTE-048 study, all major guidelines recommend PD-1 monotherapy or PD-1 combined with chemotherapy as the new first-line standard treatment for patients with advanced HNSCC. The immunotherapy in operable LA HNSCC was also explored as neoadjuvant therapy due to the excellent data in advanced HNSCC. These explorations have also achieved good results. Therefore, this study aims to explore the pathological remission rate, the long-term benefit and safety of Tislelizumab combined with albumin paclitaxel, cisplatin and fluorouracil for locally advanced oral squamous cell carcinoma.
CONDITIONS
Official Title
Neoadjuvant Treatment of Tislelizumab Combined Chemotherapy for Locally Advanced Oral Squamous Cell Carcinoma ：A Single-arm, Prospective, Phase II Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed the informed consent form
- Histopathological diagnosis of oral squamous cell carcinoma
- Age between 18 and 75 years old, any gender
- Primary tumor clinical stage III or IVb (T1-2N+M0 or T3-4N0-3M0, AJCC 2018)
- ECOG performance status of 0-1
- No previous systemic therapy for oral squamous cell carcinoma including chemotherapy, EGFR inhibitors, VEGFR inhibitors, or immune checkpoint inhibitors
- At least one measurable lesion according to RECIST v1.1
- Adequate organ function shown by laboratory tests during screening: white blood cells >3.0×10^9/L, ANC >1.5×10^9/L, platelets >75×10^9/L, hemoglobin >9 g/L
- Liver function: ALT/AST <2.5 times upper limit of normal, bilirubin <1.5 times upper limit of normal
- Renal function: serum creatinine <1.5 times upper limit of normal
- Coagulation function: INR, PT, APTT <1.5 times upper limit of normal
- Left ventricular ejection fraction ≥ 50%
- Use of contraception
You will not qualify if you...
- History of other malignancies unless cured and no recurrence for 5 years
- History of active bleeding, coagulopathy, or use of coumarin anticoagulants
- Previous radiation, chemotherapy, surgery, or immunotherapy for head and neck cancer
- Active autoimmune disease requiring systemic treatment within 2 years or likely to recur
- Active or prior inflammatory bowel disease such as Crohn's disease or ulcerative colitis
- Active pulmonary tuberculosis or syphilis infection
- Serious infections within 4 weeks before first dose or systemic anti-infective therapy within 2 weeks
- Known HIV infection
- Untreated active hepatitis B or active hepatitis C infection
- History of pneumonitis or interstitial lung disease needing corticosteroids
- Known allergy to any treatment ingredients
- Participation in another clinical trial within 30 days before enrollment
- Pregnant or breastfeeding women
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
First affiliated hospital, School of Medicine, Zhejiang University
Hangzhou, China
Actively Recruiting
Research Team
L
Lulu Liu, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here