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.
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).
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.
Parallel
SBRT
RadiationThe experimental group will first receive SBRT (Stereotactic Body Radiotherapy) for the primary tumor and positive lymph nodes (prescribed dose: 6 Gy × 3 fractions, once every other day).
Docetaxel, Cisplatin, Toripalimab
DrugToripalimab 240mg (free medicine) + Docetaxel 75mg/m2 + Cisplatin 75mg/m2, q3w for 3 courses
Radical resection surgery
Procedure/SurgeryRadical resection surgery
IMRT ± chemotherapy/toripalimab
RadiationAccording to the preoperative staging and postoperative pathological characteristics, all patients will receive postoperative radiotherapy with or without cisplatin-based chemotherapy. Additionally, patients can choose whether to continue maintenance therapy with toripalimab after surgery.
Pathological Complete Response (pCR)
pathological complete response rate after radical resection
Major Pathological Response (MPR)
The proportion of patients whose microscopic tumor cells were reduced to less than 10% as assessed by the American Joint Committee on Cancer/College of American Pathologists (AJCC/CAP) tumor regression grade (TRG) scheme for surgical specimens.
Objective response rate (ORR)
The proportion of patients with a 30% reduction in tumor volume is the sum of the complete response (CR) and partial response (PR) rates.
Disease-free survival (DFS):
The interval from the start of treatment to the earliest treatment failure due to any reason (including local recurrence, regional recurrence, distant metastasis, or death).
Overall survival (OS)
the time interval from the start of treatment to death from any cause.
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Sun Yat-sen University
Lead sponsor
Hospital of Stomatology, Sun Yat-Sen University
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
