Surgery With or Without Neoadjuvant Treatment of SBRT Plus Chemoimmunotherapy in Resectable Local… (NCT07402538) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Surgery With or Without Neoadjuvant Treatment of SBRT Plus Chemoimmunotherapy in Resectable Locally Advanced Oral and HPV-unrelated Oropharyngeal Squamous Cell Carcinoma
China184 participantsStarted 2026-02-24
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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The inclusion criteria for this study are as follows:
* Histologically and/or cytologically confirmed treatment-naĂŻve oral squamous cell carcinoma or HPV-negative oropharyngeal squamous cell carcinoma.
* Clinical stage III -â…Ła (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).
* Good organ function.
* Expected survival time: ≥ 3 months.
* The patient has signed the informed consent form and is willing and able to comply with the study's scheduled visits, treatment plans, laboratory tests, and other research procedures.
* Females of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to enrolment and must agree to use highly effective contraceptive measures during the study period and for at least 60 days after the last dose (including chemotherapeutic drugs and Tislelizumab).
* If the female partner of a male subject is still of childbearing potential, the male subject must agree to use highly effective contraceptive measures during the study period and for at least 60 days after the last dose.
Exclusion Criteria:
* 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
* Pati…
What they're measuring
1
2-year event-free survival
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to two years.