Neoadjuvant Chemotherapy Combined With Finotonlimab in the Treatment of Locally Advanced Hypopharyngeal Carcinoma

NCT07248956 · tracked via the Priya Life Science China tracker

Sponsor

Eye & ENT Hospital of Fudan University

Phase

Phase 2

Started

2025-12-22

Last updated

2025-12-23

Condition(s) studied

Hypopharyngeal Carcinoma

Investigational drug(s) / intervention(s)

FinolizumabAlbumin-Bound Paclitaxel /nab-Paclitaxel →Cisplatin →Definitive radiotherapySurgery with postoperative radiotherapy or chemoradiotherapy.

Finolizumab: 200mg every 3 weeks (q3w) for 2 cycles.

Albumin-Bound Paclitaxel /nab-Paclitaxel: 260mg/m², day 1, every 3 weeks (q3w) for 2 cycles.

Cisplatin: 25mg/m², days 1-3, every 3 weeks (q3w) for 2 cycles.

Definitive radiotherapy: Definitive radiotherapy (68-70Gy) with concurrent cisplatin-based chemotherapy (25mg/m², days 1-3, every 3 weeks)

Surgery with postoperative radiotherapy or chemoradiotherapy.: surgery with postoperative radiotherapy or chemoradiotherapy.

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: 1. Willingness to provide written informed consent; 2. Age ≥18 and ≤75 years; 3. Treatment-naïve for malignant disease; 4. Resectable stage III-IVA hypopharyngeal carcinoma with response of PR ≥ 50% after neoadjuvant therapy according to RECIST 1.1 ; 5. ECOG performance status 0-2. Exclusion Criteria: 1. Pregnancy or breastfeeding status; 2. Hypersensitivity to sintilimab, nab-paclitaxel, or their formulation components; 3. Poorly controlled cardiovascular conditions or other diseases; 4. Active or documented history of autoimmune diseases requiring systemic treatment; 5. Synchronous or metachronous malignancies; 6. Other conditions deemed ineligible for the study by investigators.

Primary outcome measure(s)

Event-free survival (EFS) — 2 years
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.

Trial sites (7)

Facility	City	Region	Status
Harbin Medical University Cancer Hospital	Harbin	Heilongjiang	Not Yet Recruiting
Shandong Provincial ENT Hospital	Jinan	Shandong	Not Yet Recruiting
Beijing Tongren Hospital, Capital Medical University	Beijing	China	Not Yet Recruiting
Cancer Hospital Chinese Academy of Medical Sciences	Beijing	China	Not Yet Recruiting
Eye & ENT Hospital, Fudan University	Shanghai	China	Recruiting
Zhongshan Hospital of Fudan University	Shanghai	China	Not Yet Recruiting
Tianjin Medical University Cancer Institute & Hospital	Tianjin	China	Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07248956 on ClinicalTrials.gov ↗ ← All trials in China