Chemoimmunotherapy With or Without SBRT Before Surgery for Locally Advanced Oral and Oropharyngea… (NCT06861712) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Chemoimmunotherapy With or Without SBRT Before Surgery for Locally Advanced Oral and Oropharyngeal Cancer
China50 participantsStarted 2025-05-06
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Oral/oropharyngeal squamous cell carcinoma confirmed by histology and/or cytology.
✓. According to the Eastern Cooperative Oncology Group (ECOG) criteria (performance status score of 0 or 1).
✓. Good organ function:
✓. Expected survival ≥ 3 months.
✓. The patient has signed an informed consent form and is willing and able to comply with the study visits, treatment plans, laboratory tests and other study procedures.
✓. Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days before enrollment and must agree to take effective contraceptive measures during the study and for at least 60 days after the last dose (including chemotherapy drugs and Teplizumab).
✕. 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.
✕. Patients with severe heart disease, pulmonary dysfunction, heart function and pulmonary function below grade 3 (including grade 3).
✕. Patients whose laboratory test values do not meet the relevant standards within 7 days before enrollment.
✕. Patients who have received systemic or local glucocorticoid treatment within 4 weeks before enrollment.
✕. Patients with complications that require long-term use of immunosuppressive drugs or systemic or local use of corticosteroids with immunosuppressive effects.