Neoadjuvant Toripalimab and Paclitaxel/Cisplatin on Pathological Response in Oral Squamous Cell Carcinoma Patients
Condition: Oral Cancer; Induction Chemotherapy; Programmed Cell Death 1 Inhibitor; Inductive Therapy
MeSH terms: Carcinoma, Squamous Cell; Mouth Neoplasms; Squamous Cell Carcinoma of Head and Neck
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to use the combination of immune checkpoint inhibitor of
      Toripalimab, and chemotherapy agents of TP, as a neoadjuvant therapy to treat the patients
      with locally advanced OSCC, followed with radical surgery and post-operative
      radiotherapy/chemoradiotherapy, the major pathological response and safety will be evaluated
      as the primary surrogate endpoints, the 2-year survival rate and local recurrence rate will
      be the second endpoints.
    

Detailed description: 
      In patients with locally advanced oral squamous cell carcinoma (OSCC), comprehensive
      treatment is recommended, including surgery, radiotherapy, chemotherapy and others.
      Pre-operative neoadjuvant therapy can reduce tumor burden, increase organ preservation rate,
      and reduce distant metastasis rate. Pre-operative neoadjuvant therapy with paclitaxcel and
      cisplatin (TP) has been used as one of recommended protocols in patients with locally
      advanced head and neck squamous cell caricnoma, including OSCC. Anti-PD1/PD-L1
      immunotherapies have achieved exciting clinical outcomes in several malignancies, such as
      lung cancer, breast cancer, and so on. Recently, pre-operative neoadjuvant therapy with
      combination of immunotherapy and chemotherapy agents has been used with good pathological
      response, which might transfer to good clinical prognosis in patients with malignancies.
      However, pre-operative neoadjuvant therapy with combination of anti-PD1 and TP in OSCC
      patients has not been reported. The innovation of this study is the combination of immune
      checkpoint inhibitor of Toripalimab, and chemotherapy agents of TP, as a neoadjuvant therapy
      to treat the patients with locally advanced OSCC, followed with radical surgery and
      post-operative radiotherapy/chemoradiotherapy, the major pathological response and safety
      will be evaluated as the primary surrogate endpoints, the 2-year survival rate and local
      recurrence rate will be the second endpoints.
    

Intervention name(s): Toripalimab; Paclitaxcel; Cisplatin; Radical surgery; Post-operative radiotherapy/chemoradiotherapy
Intervention type(s): Drug; Drug; Drug; Procedure; Radiation
Intervention description(s): Neoadjuvant therapy with Toripalimab of 240mg, iv, qd, on day 1, 22; Neoadjuvant therapy with Paclitaxcel of 260mg/m2, iv, qd, on day 1, 22; Neoadjuvant therapy with Cisplatin of 75mg/m2, iv, qd, on day 1, 22; Radical surgery will be performed on the 43th-48th after initiation of inductive therapy.; Post-operative radiotherapy/chemoradiotherapy will be performed within 1.5 months after radical surgery, depending on the post-operative pathological diagnosis.
Other intervention name(s): Toripalimab for Injection; Paclitaxel for Injection (Albumin Bound); Cisplatin for Injection
Intervention MeSH terms: Paclitaxel; Cisplatin
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment