Surgery With or Without Neoadjuvant Treatment of SBRT Plus Chemoimmunotherapy in Resectable Locally Advanced Oral and HPV-unrelated Oropharyngeal Squamous Cell Carcinoma

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University

About this trial

The objective of this study is to evaluate the efficacy of neoadjuvant stereotactic body radiation therapy (SBRT) in combination with chemotherapy and immunotherapy, prior to radical surgery, in enhancing the 2-year event-free survival rate and overall survival rate in patients diagnosed with locally advanced oral or HPV-unrelated oropharyngeal cancer.

Eligibility criteria

Qualifiers

Histologically and/or cytologically confirmed treatment-naïve oral squamous cell carcinoma or HPV-negative oropharyngeal squamous cell carcinoma.

Clinical stage III -Ⅳa (8th edition of AJCC).

Age: 18 to 75 years old.

According to the Eastern Cooperative Oncology Group (ECOG) criteria (with a performance status score of 0 or 1).

Disqualifiers

Patients with concurrent other malignant tumors

Patients with known or suspected autoimmune diseases, including dementia and epilepsy.

Patients with severe mental disorders at the same time

Patients with necrotic lesions who are assessed by the investigator as having a risk of massive hemorrhage

Trial design

Treatments tested in this trial

  • Neoadjuvant treatment of SBRT plus chemoimmunotherapy followed by surgery and postoperative radiotherapy or chemoradiotherapy
  • Surgery and postoperative radiotherapy or chemoradiotherapy

Treatment groups

184 Participants
are divided into 2 treatment groups

Sponsors and collaborators