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.
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).
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
Parallel
Neoadjuvant treatment of SBRT plus chemoimmunotherapy followed by surgery and postoperative radiotherapy or chemoradiotherapy
Combination productThe 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.
Surgery and postoperative radiotherapy or chemoradiotherapy
Combination productRadical surgery followed by postoperative radiotherapy or chemoradiotherapy with cisplatin at a dose of 100 mg/m² for three cycles.
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.
2-year overall survival
The time interval from random start to death for any cause.
MPR
Proportion of patients with ≤10% viable tumor cells identified per AJCC/CAP Tumor Regression Grading (TRG) protocol evaluation of surgical specimens.
pCR
Proportion of patients with no viable tumor cells identified upon complete and systematic evaluation of postoperative specimens under the AJCC/CAP Tumor Regression Grading (TRG) protocol, including microscopic examination of all sampled primary tumor sites and regional lymph nodes.
Mandibular Preservation Rate
Proportion of oral cancer patients retaining mandibular continuity after primary tumor resection.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
