Chemoimmunotherapy With or Without SBRT Before Surgery for Locally Advanced Oral and Oropharyngeal Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSun Yat-sen University

About this trial

In this study, participants will be randomly assigned to either the experimental group or the control group. The experimental group will first receive SBRT (6Gy\*3 fractions) to treat the primary tumor and metastatic lymph nodes. This will be followed by a combination of Toripalimab, Docetaxel, and Cisplatin for three cycles, every three weeks. The control group will receive the same combination of Toripalimab, Docetaxel, and Cisplatin for three cycles, every three weeks, but without SBRT. After the final round of chemotherapy, all participants will have imaging scans and, three weeks later, undergo surgery. After surgery, they may also receive additional radiotherapy with or without chemotherapy. Patients can also choose whether to continue treatment with Toripalimab after surgery.

Eligibility criteria

Qualifiers

Oral/oropharyngeal squamous cell carcinoma confirmed by histology and/or cytology.

Clinical stage: resectable oral/oropharyngeal squamous cell carcinoma stage III-IVa (AJCC 8th edition)

Age: 18-65 years old.

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

Disqualifiers

Patients with other malignant tumors.

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

Patients with severe mental illness.

Patients with necrotic lesions and who are assessed by the researchers to be at risk of major bleeding.

Trial design

Treatments tested in this trial

  • SBRT
  • Docetaxel, Cisplatin, Toripalimab
  • Radical resection surgery
  • IMRT ± chemotherapy/toripalimab

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Sun Yat-sen University

Lead sponsor

Hospital of Stomatology, Sun Yat-Sen University

Collaborator