Actively Recruiting
Tirilizumab with Albumin-bound Paclitaxel and Cisplatin for Locally Advanced Resectable Oral Squamous Cell Carcinoma
Led by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Updated on 2025-02-11
116
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The dosing regimen in the trial group was: tirilizumab with albumin-bound paclitaxel and cisplatin for 3 preoperative Cycles. After neoadjuvant therapy, patients underwent surgery and were stratified according to pathological conditions after surgery; if significant pathological remission (MPR) was achieved, 6 cycles of adjuvant therapy with tirilizumab monotherapy (concurrent radiochemotherapy was available for those with high-risk factors) were performed; if MPR was not achieved, concurrent radiochemotherapy was performed. Control regimen: patients underwent direct surgical treatment, with postoperative radiotherapy or radiochemotherapy depending on the presence or absence of histological or pathological high-risk factors.
CONDITIONS
Official Title
Tirilizumab with Albumin-bound Paclitaxel and Cisplatin for Locally Advanced Resectable Oral Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years, male or female
- Primary stage III-IVa surgically resectable squamous cell carcinoma of the oral cavity
- Measurable lesions ≥10 mm on spiral CT scan meeting RECIST 1.1 criteria confirmed by pathology
- ECOG performance status of 0 or 1
- Expected survival of at least 12 weeks
- Tumor tissue available for PD-L1 detection (paraffin or fresh tissue less than 2 years old)
- Adequate bone marrow function: ANC ≥1.5 x 10^9/L, platelets ≥100 x 10^9/L, hemoglobin ≥9 g/dL without recent transfusion
- Adequate liver function: total bilirubin ≤1.5 x upper limit normal, AST and ALT ≤2.5 x upper limit normal (≤5 x if liver metastasis)
- Adequate kidney function: creatinine <1.5 x upper limit normal or creatinine clearance ≥60 ml/min, urea nitrogen ≤200 mg/L
- Thyroid-stimulating hormone ≤1 x upper limit normal; if abnormal, normal FT3 and FT4 levels required
- Urine protein ≤1+; if >1+, 24-hour urine protein ≤1 g
- Normal cardiac function: normal ECG or insignificant abnormalities, LVEF >50% by ultrasound
- Negative serum pregnancy test for reproductively active females
- Use of highly effective contraception by reproductively active males and females during and for 90 days after treatment
- Volunteered and signed informed consent, compliant with follow-up visits
You will not qualify if you...
- Presence of distant metastases or unresectable local lesions (stage IVb or IVc)
- History of primary nasopharyngeal carcinoma
- Participation in another drug or therapy clinical trial within 4 weeks prior to first dose
- Major surgery within 4 weeks prior to first dose or incomplete recovery from surgery side effects
- Live vaccination, immunotherapy, or radiotherapy within 2 weeks prior to first dose
- Concurrent treatment with other anti-tumor therapies
- Active autoimmune disease or history of autoimmune disease requiring systemic therapy
- Ongoing immunosuppressive or systemic hormone therapy (>10 mg/day prednisone or equivalent) within 2 weeks prior to enrollment
- History of other cancers within past 5 years except certain cured skin cancers, early prostate cancer, or carcinoma in situ of cervix
- Use of hematopoietic stimulating factors within 1 week prior to first dose
- Prior treatment with PD-1/PD-L1/PD-L2/CTLA-4 antibodies or T-cell receptor targeting drugs
- Positive HIV, syphilis, active hepatitis B or C infections
- Known hypersensitivity to recombinant humanized PD-1 monoclonal antibodies
- Active lung disease or history of active tuberculosis
- Uncontrolled clinical problems including serious infections, uncontrolled hypertension, poorly controlled diabetes, severe heart disease
- Major cardiovascular events or procedures within 6 months prior to first dose
- Previous stem cell or organ transplant
- History of psychotropic substance abuse or psychotic disorders
- Other severe medical conditions or abnormal labs increasing risk or interfering with study
- Poor compliance or conditions unsuitable for trial participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200011
Actively Recruiting
Research Team
Y
Yanan Wang, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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