This is a multi-center, randomized controlled, prospective clinical study.
Willingness to provide written informed consent;
Age ≥18 and ≤75 years;
Treatment-naïve for malignant disease;
Resectable stage III-IVA hypopharyngeal carcinoma with response of PR ≥ 50% after neoadjuvant therapy according to RECIST 1.1 ;
Pregnancy or breastfeeding status;
Hypersensitivity to sintilimab, nab-paclitaxel, or their formulation components;
Poorly controlled cardiovascular conditions or other diseases;
Active or documented history of autoimmune diseases requiring systemic treatment;
Parallel
Finolizumab
Drug200mg every 3 weeks (q3w) for 2 cycles.
Albumin-Bound Paclitaxel /nab-Paclitaxel
Drug260mg/m², day 1, every 3 weeks (q3w) for 2 cycles.
Cisplatin
Drug25mg/m², days 1-3, every 3 weeks (q3w) for 2 cycles.
Definitive radiotherapy
RadiationDefinitive radiotherapy (68-70Gy) with concurrent cisplatin-based chemotherapy (25mg/m², days 1-3, every 3 weeks)
Surgery with postoperative radiotherapy or chemoradiotherapy.
Procedure/Surgerysurgery with postoperative radiotherapy or chemoradiotherapy.
Event-free survival (EFS)
Duration from treatment initiation until the first occurrence of any of the following events: disease progression precluding surgical intervention, local or distant recurrence, death from any cause, etc.
Overall Survival (OS)
Duration from the date of tumor treatment initiation to the date of first documented death from any cause or the last follow-up date.
Locoregional Control Rate (LRFS)
Duration from the date of tumor treatment initiation to the date of first documented locoregional recurrence, death from any cause, or the last follow-up date.
Laryngeal Preservation Rate
The proportion of patients who successfully retain laryngx function after treatment.
Major Pathological Response Rate (MPR)
The presence of ≤10% viable invasive squamous cell carcinoma in the resected primary tumor and neck lymph nodes.
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