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.
Participants will be randomly assigned to the experimental group and the control group. The 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). One to two weeks after SBRT, they will receive 240 mg of Toripalimab + 75 mg/m² of Docetaxel + 75 mg/m² of Cisplatin, administered every 3 weeks for 3 cycles. The control group will receive 240 mg of Toripalimab + 75 mg/m² of Docetaxel + 75 mg/m² of Cisplatin, administered every 3 weeks for 3 cycles. Both groups will undergo imaging assessment 2 weeks after the final chemotherapy cycle. Three weeks after the last chemotherapy cycle, participants will receive curative surgery. Postoperative adjuvant radiotherapy ± chemotherapy will be administered according to preoperative staging and postoperative pathological characteristics. Patients may also choose to continue maintenance treatment with Toripalimab after surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
The 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).
Toripalimab 240mg (free medicine) + Docetaxel 75mg/m2 + Cisplatin 75mg/m2, q3w for 3 courses
Radical resection surgery
According 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.
Department of Radiation Oncology, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Pathological Complete Response (pCR)
pathological complete response rate after radical resection
Time frame: 2 weeks after the surgery
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.
Time frame: 2 weeks after the surgery
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.
Time frame: two weeks after the chemoimmunotherapy
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).
Time frame: 2 years
Overall survival (OS)
the time interval from the start of treatment to death from any cause.
Time frame: 2 years
Mandibular preservation rate:
the proportion of patients with oral cancer whose mandibular continuity is preserved after primary lesion surgery.
Time frame: immediately after the surgery
Incidence of adverse events (AEs) and serious adverse events (SAEs)
the proportion of patients with adverse events of grade 3 or above among all patients.
Time frame: one month after the postoperative radiotherapy
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