This prospective, single-arm, Phase II clinical trial aims to evaluate the efficacy and safety of tislelizumab combined with chemotherapy as neoadjuvant therapy and postoperative adjuvant immunotherapy in patients with skull base-invading head and neck squamous cell carcinoma. The primary objectives are to address the following questions: * What are the objective response rate and pathological response of tislelizumab combined with chemotherapy as neoadjuvant therapy in patients with skull base-invading head and neck squamous cell carcinoma? * Can neoadjuvant therapy convert unresectable skull base-invading head and neck squamous cell carcinoma into a resectable condition? * Can adjuvant immunotherapy after neoadjuvant therapy prolong patients' recurrence-free survival and overall survival? The researchers will administer neoadjuvant therapy (tislelizumab combined with chemotherapy) and adjuvant immunotherapy to patients with skull base-invading head and neck squamous cell carcinoma and assess the treatment's efficacy and safety. Participants will: * Receive neoadjuvant therapy every 3 weeks (tislelizumab 200mg on Day 1, nab-paclitaxel 260mg/m² on Day 1, cisplatin 75mg/m² on Days 1-3) for 3 cycles. * Undergo surgical treatment within 3 weeks after completing neoadjuvant therapy. * Receive (chemo)radiotherapy 4-6 weeks after surgery. * Receive adjuvant immunotherapy (tislelizumab 200mg) every 3 weeks after (chemo)radiotherapy for 8 cycles.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
* Neoadjuvant therapy is administered every 3 weeks (Tislelizumab 200mg D1, Nab Paclitaxel 260mg/m² D1, Cisplatin 75mg/m² D1-3) for a total of 3 cycles. * Surgical treatment is performed within 3 weeks after completing neoadjuvant therapy. * Postoperative (chemo)radiotherapy is initiated 4-6 weeks after surgery. * Following (chemo)radiotherapy, adjuvant immunotherapy (Tislelizumab 200mg) is administered every 3 weeks for a total of 8 cycles.
Neoadjuvant therapy is administered every 3 weeks (Tislelizumab 200mg D1, Nab Paclitaxel 260mg/m² D1, Cisplatin 75mg/m² D1-3) for a total of 3 cycles.
Hospital of Stomatology, Sun Yat-sen University
Guangzhou, Guangdong, China
Objective response rate
Objective Response Rate (ORR) is a pivotal efficacy endpoint in oncology therapeutic evaluation, defined as the proportion of patients whose tumor burden shrinks to a prespecified threshold (achieving either complete or partial response). This metric is measured using internationally standardized criteria (RECIST 1.1), with radiographic imaging to monitor changes in the sum of target lesion diameters. Based on Standardized Criteria (e.g., RECIST 1.1). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): ≥30% decrease in tumor size (sum of target lesions). ORR = CR + PR (expressed as a percentage).
Time frame: Within 3 weeks after completion of neoadjuvant therapy
Number of participants with Adverse Events
To evaluate the adverse events during the study period according to the NCI-CTCAE, version 5.0, including vital signs, physical examination, laboratory tests, changes in ECOG score, etc., as well as adverse events and serious adverse events, are calculated to the incidence of adverse events and serious adverse events.
Time frame: Until 21 days after the end of the study
Pathologic Efficacy
The percentage of residual tumor cells in tumor bed of pathological specimens after surgery. Pathological complete response (pCR) refers to tumors the absence of any viable tumor cells within the tumor bed. Major pathological response (MPR) is defined as 10% or fewer residual viable tumor cells within the tumor bed.
Time frame: Perioperative
Clinical Downstaging Rate
The proportion of patients with reduction in clinical TNM stage.
Time frame: Within 3 weeks after completion of neoadjuvant therapy.
Surgical Conversion Rate
The proportion of patients with initially unresectable tumors that become resectable after treatment.
Time frame: Within 3 weeks after completion of neoadjuvant therapy.
R0 Resection Rate
The proportion of patients achieving complete tumor removal with microscopically negative margins (no residual tumor cells).
Time frame: Perioperative
Organ Preservation Rate
The proportion of patients who, despite pretreatment tumor invasion into critical organs (e.g., eyeball, internal carotid artery, dura mater), successfully retain the involved organ while still achieving R0 resection.
Time frame: Perioperative
Recurrence-Free Survival
The time from enrollment until cancer recurrence or death from any cause.
Time frame: Until cancer recurrence or death or the last follow-up, whichever came first, assessed up to 24 months
Overall Survival
The time from enrollment until death from any cause or the last follow-up.
Time frame: Until death from any cause or the last follow-up, whichever came first, assessed up to 24 months
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