NCT07248956

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: Eye & ENT Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, randomized controlled, prospective clinical study.

Detailed description

The early symptoms of hypopharyngeal cancer are often inconspicuous, with approximately 70% of patients clinically diagnosed at an advanced stage. With the emergence of immunotherapy, immune therapies such as PD-1 inhibitors combined with induction chemotherapy have been widely explored in various tumor types. Currently, there is a lack of large-scale real-world studies on the efficacy and safety of treatment options for patients with locally advanced hypopharyngeal cancer who respond well to neoadjuvant therapy. This study aims to employ neoadjuvant chemotherapy combined with immunotherapy for locally advanced hypopharyngeal cancer and explore the effectiveness and safety of different subsequent treatment options for patients assessed as achieving a major partial response (PR ≥50%).

Conditions

• Hypopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	Finolizumab	200mg every 3 weeks (q3w) for 2 cycles.
DRUG	Albumin-Bound Paclitaxel /nab-Paclitaxel	260mg/m², day 1, every 3 weeks (q3w) for 2 cycles.
DRUG	Cisplatin	25mg/m², days 1-3, every 3 weeks (q3w) for 2 cycles.
RADIATION	Definitive radiotherapy	Definitive radiotherapy (68-70Gy) with concurrent cisplatin-based chemotherapy (25mg/m², days 1-3, every 3 weeks)
PROCEDURE	Surgery with postoperative radiotherapy or chemoradiotherapy.	surgery with postoperative radiotherapy or chemoradiotherapy.

Timeline

• Start date: 2025-12-22
• Primary completion: 2027-11-30
• Completion: 2029-12-30
• First posted: 2025-11-25
• Last updated: 2025-12-23

Locations

7 sites across 1 country: China