Actively Recruiting
A Prospective, Randomised Controlled, Phase II Clinical Study of Tirilizumab in Combination with Albumin-bound Paclitaxel and Cisplatin for Neoadjuvant and Adjuvant Treatment of 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
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating tirilizumab combined with albumin-bound paclitaxel and cisplatin for treating patients with locally advanced resectable oral squamous cell carcinoma. This randomized phase II study compares this combination neoadjuvant and adjuvant therapy approach to standard surgical treatment followed by radiotherapy or radiochemotherapy depending on risk factors. The study aims to assess event-free survival and pathological remission among other outcomes to improve treatment strategies for this cancer type. Participants in the trial receive tirilizumab intravenously at 200 mg every three weeks, alongside three preoperative cycles of albumin-bound paclitaxel and cisplatin administered every 21 days. After surgery, patients are grouped based on their pathological remission status; those with significant remission receive six cycles of tirilizumab alone as adjuvant therapy, with optional concurrent radiochemotherapy for high-risk cases. Patients without remission undergo concurrent radiochemotherapy. The control group undergoes direct surgery followed by postoperative radiotherapy or radiochemotherapy based on pathological risk factors. During the study, patients will be monitored through regular assessments including survival rates, adverse events, quality of life questionnaires, and pathological remission rates over up to 36 months. Organ function, cardiac health, and tumor tissue PD-L1 status are evaluated prior to treatment. The trial includes follow-up visits to track treatment effects and safety, with total involvement extending to three years to observe long-term outcomes and survival.
CONDITIONS
Brief 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 with measurable lesions (≥10 mm on spiral CT scan, meeting RECIST 1.1 criteria)
- ECOG performance status of 0 or 1
- Expected survival of at least 12 weeks
- Available tumor tissue for PD-L1 detection (paraffin specimen or fresh tissue less than 2 years old)
- Adequate organ function including bone marrow, liver, kidney, thyroid, urine protein, and normal cardiac function
- Negative serum pregnancy test for reproductively active females before first dose
- Use of highly effective contraception throughout the trial and for 90 days after treatment
- Signed informed consent and willingness to comply with follow-up visits
You will not qualify if you...
- Distant metastases or localized lesions not suitable for surgery (stage IVb or IVc)
- Prior nasopharyngeal carcinoma
- Participation in another drug trial within 4 weeks before first dose
- Major surgery, live vaccination, immunotherapy, or radiotherapy within 4 weeks or 2 weeks depending on type
- Concurrent use of other anti-tumor therapies
- Active or history of autoimmune disease or use of immunosuppressive/systemic hormone therapy within 2 weeks prior to enrollment
- History of other cancers within 5 years except certain skin and early prostate cancers
- Recent use of hematopoietic stimulating factors within 1 week
- Prior treatment with PD-1/PD-L1/CTLA-4 or related drugs
- Positive HIV, syphilis, active hepatitis B or C infection
- Known hypersensitivity to PD-1 monoclonal antibodies
- Active lung diseases or history of active tuberculosis
- Uncontrolled clinical problems including severe infections, hypertension, diabetes, heart diseases, recent thrombotic or cardiovascular events, transplants, psychotropic substance abuse, psychotic disorders
- Other severe medical conditions or poor compliance that may increase risks or interfere with study results
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 9 weeks
Participants receive 3 preoperative cycles of tirilizumab combined with albumin-bound paclitaxel and cisplatin administered every 3 weeks.
3 treatment visits every 3 weeks
Duration - Surgery day plus immediate recovery period
Participants undergo surgery to remove the tumor and are assessed for pathological remission.
1 surgical visit (in-person)
Duration - Up to 18 weeks
Participants with significant pathological remission receive 6 cycles of tirilizumab monotherapy every 3 weeks; those without remission receive concurrent radiochemotherapy.
6 treatment visits every 3 weeks
Duration - Up to 36 months
Participants are followed to assess long-term outcomes including survival and quality of life.
Visits scheduled periodically during follow-up
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.
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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