Neoadjuvant immunotherapy before surgery has shown good efficacy and safety in locally advanced HNSCC, particularly with the use of PD-1 inhibitors combined with chemotherapy, where some patients have achieved a high rate of pathological complete response. However, approximately 40% of patients respond poorly to neoadjuvant immunochemotherapy, with prolonged treatment courses failing to significantly improve outcomes, and some patients may even experience disease progression. For these patients, timely surgery or definitive radiotherapy combined with other well-tolerated therapeutic approaches is needed to improve pathological response rates, enhance long-term survival, and preserve organ function.
In recent years, the introduction of PD-1 inhibitors has revolutionized cancer treatment, including head and neck squamous cell carcinoma (HNSCC). Data from The Cancer Genome Atlas (TCGA) shows HNSCC is one of the most immunogenic cancers, linked to immune dysfunction such as impaired immune cell function and antigen presentation defects. Immunotherapy, alone or combined with chemotherapy, has become the standard first-line treatment for recurrent or metastatic HNSCC, as supported by clinical trials like Keynote-040, Keynote-048, and CheckMate 141, which demonstrated improved patient outcomes. There is also growing interest in neoadjuvant immunotherapy for locally advanced HNSCC. A phase II clinical trial (NCT03174275) showed that neoadjuvant camrelizumab combined with cisplatin and paclitaxel achieved a pathologic complete response (pCR) rate of 37% and a major pathological response (MPR) rate of 74%. Another trial combining PD-1 inhibitor tislelizumab with nab-paclitaxel, platinum, and fluorouracil reported an objective response rate (ORR) of 85.7% and a pCR rate of 42.9%. In a retrospective analysis of 110 locally advanced oral cavity squamous cell carcinoma (OCSCC) patients treated at our institution, the ORR after two cycles of neoadjuvant immunochemotherapy was 55.4%, with 41% of patients showing stable disease (SD). Further treatment cycles did not improve outcomes for these patients, highlighting the need for alternative treatments for those unresponsive to neoadjuvant therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Patient will receive SBRT (8Gy\*3F) in combination with the original regimen of neoadjuvant immunochemotherapy in course 3. Gross tumor target volume (GTV) based on the primary foci clearly identified by clinical and imaging examinations. The GTV was discharged 3 mm to generate a Planning target volume (PTV). the target area (PTV) was dosed accordingly to the PTV.
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Objective response rate
Proportion of subjects containing complete response and partial response, i.e., the sum of the diameters of the target lesions is at least 30% smaller compared to baseline, derived from the RECIST v1.1 criteria at 3 weeks after the 3rd course of Neoadjuvant immunochemotherapy + SBRT, including by imaging assessment.
Time frame: 3 weeks after the 3rd course of Neoadjuvant immunochemotherapy + SBRT, including by imaging assessment.
Overall response rate
The percentage of patients with a best overall response of CR or PR relative to the efficacy evaluable population.
Time frame: 3 weeks after the 3rd course of Neoadjuvant immunochemotherapy + SBRT, including by imaging assessment.
Pathological complete response
No surviving tumor cells are found in a sample of a completely resected tumor.
Time frame: 10days after surgery
Major pathologic response
Percentage of residual viable tumor cells ≤10% in samples of completely resected tumors.
Time frame: 10days after surgery
Pathological partial response
Percentage of residual viable tumor cells \>10%, ≤70% in samples of completely resected tumors.
Time frame: 10days after surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.