Neoadjuvant Treatment of Tislelizumab Combined Chemotherapy for Locally Advanced Oral Squamous Cell Carcinoma :A Single-arm, Prospective, Phase II Trial

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorWeijia Fang, MD

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

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

Weijia Fang, MD

Lead sponsor

Zhejiang University

Sponsor institution