RecruitingPhase 2NCT07248956
Neoadjuvant Chemotherapy Combined With Finotonlimab in the Treatment of Locally Advanced Hypopharyngeal Carcinoma
Neoadjuvant Chemotherapy Combined With Finotonlimab in the Treatment of Locally Advanced Hypopharyngeal Carcinoma: A Multicenter Randomized Controlled Study
Sponsor
Eye & ENT Hospital of Fudan University
Enrollment
116 participants
Start Date
Dec 22, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
This is a multi-center, randomized controlled, prospective clinical study.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria5
- 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 ;
- ECOG performance status 0-2.
Exclusion Criteria6
- 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;
- Synchronous or metachronous malignancies;
- Other conditions deemed ineligible for the study by investigators.
Interventions
DRUGFinolizumab
200mg every 3 weeks (q3w) for 2 cycles.
DRUGAlbumin-Bound Paclitaxel /nab-Paclitaxel
260mg/m², day 1, every 3 weeks (q3w) for 2 cycles.
DRUGCisplatin
25mg/m², days 1-3, every 3 weeks (q3w) for 2 cycles.
RADIATIONDefinitive radiotherapy
Definitive radiotherapy (68-70Gy) with concurrent cisplatin-based chemotherapy (25mg/m², days 1-3, every 3 weeks)
PROCEDURESurgery with postoperative radiotherapy or chemoradiotherapy.
surgery with postoperative radiotherapy or chemoradiotherapy.
Locations(7)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07248956
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