Surgery With or Without Neoadjuvant Treatment of SBRT Plu... | NCT07402538

NCT07402538

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Neoadjuvant treatment followed by surgery arm	Experimental	Initially, the patient underwent neoadjuvant treatment, including stereotactic body radiotherapy (SBRT) followed by chemoimmunotherapy of Tislelizumab (200 mg), Docetaxel (75 mg/m²), and Cisplatin (75 mg/m²). A subsequent imaging re-examination is to be performed for assessment two weeks after the last chemotherapy cycle. Finally, curative surgical resection should be performed 3-4 weeks after the last chemotherapy cycle, followed by adjuvant postoperative radiotherapy or chemoradiotherapy.	Combination Product: Neoadjuvant treatment of SBRT plus chemoimmunotherapy followed by surgery and postoperative radiotherapy or chemoradiotherapy
Surgery arm	Active Comparator	Radical surgery followed by postoperative radiotherapy or chemoradiotherapy.	Combination Product: Surgery and postoperative radiotherapy or chemoradiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neoadjuvant treatment of SBRT plus chemoimmunotherapy followed by surgery and postoperative radiotherapy or chemoradiotherapy	Combination Product	The patient was initially subjected to a neoadjuvant treatment regime, encompassing stereotactic body radiotherapy (SBRT) and chemoimmunotherapy. The SBRT was administered with a dose of 6 Gy per fraction to the primary tumour and metastatic lymph nodes, administered every other day for a total of three fractions. Following this, a period of one to two weeks was to elapse before the initiation of Tislelizumab (200 mg), Docetaxel (75 mg/m²), and Cisplatin (75 mg/m²), on a three-week cycle, for a total of two cycles. A subsequent imaging re-examination was to be performed for assessment two weeks after the final chemotherapy cycle. Finally, curative surgical resection was to be performed 3-4 weeks after the final chemotherapy cycle, followed by adjuvant postoperative radiotherapy or chemoradiotherapy with cisplatin at a dose of 100 mg/m² for two cycles.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
2-year event-free survival	The time interval from randomization to the occurrence of imaging tumor progression during the neoadjuvant treatment stage that makes surgery impossible, or postoperative imaging or biopsy results show local tumor recurrence, lymph node recurrence, distant metastasis, or death for any cause.	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.

Secondary Outcomes

Measure	Description	Time Frame
2-year overall survival	The time interval from random start to death for any cause.	From date of randomization until the date of death from any cause, assessed up to two years.
MPR	Proportion of patients with ≤10% viable tumor cells identified per AJCC/CAP Tumor Regression Grading (TRG) protocol evaluation of surgical specimens.

Eligibility Module

Eligibility Criteria

The inclusion criteria for this study are as follows:

Histologically and/or cytologically confirmed treatment-naïve oral squamous cell carcinoma or HPV-negative oropharyngeal squamous cell carcinoma.
Clinical stage III -Ⅳa (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
Patients with severe heart disease or pulmonary dysfunction, and those with cardiac or pulmonary function grade ≤ 3 (grade 3 inclusive)
Patients with laboratory test results that do not meet the relevant criteria within 7 days prior to enrollment
Received systemic or local glucocorticoid therapy within 4 weeks prior to enrollment
Patients with comorbidities requiring long-term treatment with immunosuppressive drugs, or requiring systemic or local administration of corticosteroids at immunosuppressive doses.
Patients with active tuberculosis (TB), who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year prior to screening.
A history of prior use of anti-Tislelizumab, anti-PD-L1 antibodies, anti-PD-L2 antibodies, or anti-CTLA-4 antibodies (or any other antibodies targeting T-cell co-stimulation or checkpoint pathways).
Subjects with any active autoimmune diseases or a history of autoimmune diseases (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism); subjects with vitiligo or those whose childhood asthma has been completely relieved and who do not require any intervention in adulthood are eligible for enrollment; those with asthma requiring medical intervention with bronchodilators are not eligible for enrollment.
HIV-positive subjects
Positive for HBsAg with concurrent positive HBV DNA copy number (quantitative test ≥ 1000 cps/ml); positive for chronic hepatitis C on blood screening (HCV antibody positive)
Received any anti-infective vaccines (such as influenza vaccine, varicella vaccine, etc.) within 4 weeks prior to enrollment
Pregnant women with positive pregnancy test results among females of childbearing potential and lactating women.

Name	Affiliation	Role
Fang-Yun Xie, M.D.	Sun Yat-Sen University Cancer Center	Principal Investigator
Ming Song, M.D.	Sun Yat-Sen University Cancer Center	Principal Investigator

ID	Term
D009062	Mouth Neoplasms
D009959	Oropharyngeal Neoplasms

ID	Term
D006258	Head and Neck Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D010610	Pharyngeal Neoplasms
D010039	Otorhinolaryngologic Neoplasms
D010608	Pharyngeal Diseases
D010038	Otorhinolaryngologic Diseases

ID	Term
D059248	Chemoradiotherapy
D013514	Surgical Procedures, Operative

ID	Term
D003131	Combined Modality Therapy
D013812	Therapeutics
D004358	Drug Therapy
D011878	Radiotherapy