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

Plain Language Summary

Simplified for easier understanding

This study investigates a combination treatment for locally advanced cancer of the hypopharynx (the lower part of the throat). It combines an immune checkpoint drug called finotonlimab with chemotherapy (nab-paclitaxel) given before surgery, to see if it improves outcomes while preserving the ability to speak and swallow. **You may be eligible if...** - You are between 18 and 75 years old - You have been newly diagnosed with stage III or IVA hypopharyngeal cancer and have not yet received treatment - Your tumor showed at least 50% shrinkage after the initial chemotherapy phase - You are in good general health (ECOG performance score 0–2) **You may NOT be eligible if...** - You are pregnant or breastfeeding - You are allergic to any of the study drugs - You have poorly controlled heart disease or other serious health conditions - You have a history of active autoimmune disease requiring systemic treatment - You have had another cancer at the same time or in the past Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Shandong Provincial ENT Hospital

Jinan, Shandong, China

Beijing Tongren Hospital, Capital Medical University

Beijing, China

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

Eye & ENT Hospital, Fudan University

Shanghai, China

Zhongshan Hospital of Fudan University

Shanghai, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

View Full Details on ClinicalTrials.gov

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NCT07248956


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