About this trial
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.
Eligibility criteria
Qualifiers
Signed the informed consent form
Histopathological diagnosis of oral squamous cell carcinoma
Age: 18-75 years old , Gender: male and female
Primary tumor with a clinical stage of III/IVb (T1-2N+M0或T3-4N0-3M0, AJCC2018)
Disqualifiers
Known history of malignancy, unless been cured and no recurrence for 5 years
Patients with a history of active bleeding, coagulopathy, or receiving coumarin anticoagulation therapy
Known history of radiation, chemotherapy, surgery and immunology-based treatment to head and neck
Active autoimmune disease requiring systemic treatment within 2 years prior to the first dose, or autoimmune disease that may recur or plan treatment as judged by the investigator.
Trial design
Treatments tested in this trial
- Tislelizumab
- Albumin paclitaxel
- Cisplatin
- 5-Fluorouracil
Treatment groups
Sponsors and collaborators
Weijia Fang, MD
Lead sponsor
Zhejiang University
Sponsor institution