Neoadjuvant Chemotherapy Combined With Finotonlimab in the Treatment of Locally Advanced Hypopharyngeal Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Finolizumab, Albumin-Bound Paclitaxel /nab-Paclitaxel, Cisplatin, Definitive radiotherapy.
- Who it may be relevant to
- Registry conditions: Hypopharyngeal Carcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Neoadjuvant Chemotherapy Combined With Finotonlimab in the Treatment of Locally Advanced Hypopharyngeal Carcinoma: A Multicenter Randomized Controlled Study
Overview
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%).
Interventions
- 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.
Primary outcome measures
- Event-free survival (EFS) [Time frame: 2 years]
Secondary outcome measures (5)
- Overall Survival (OS) [Time frame: 2 years]
- Locoregional Control Rate (LRFS) [Time frame: 2 years]
- Laryngeal Preservation Rate [Time frame: 2 years]
- Major Pathological Response Rate (MPR) [Time frame: 2 years]
- Adverse events [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 7 centers
- Harbin Medical University Cancer Hospital — Harbin
- Shandong Provincial ENT Hospital — Jinan
- Beijing Tongren Hospital, Capital Medical University — Beijing
- Cancer Hospital Chinese Academy of Medical Sciences — Beijing
- Eye & ENT Hospital, Fudan University — Shanghai
- Zhongshan Hospital of Fudan University — Shanghai
- Tianjin Medical University Cancer Institute & Hospital — Tianjin
Identifiers
NCT: NCT07248956 · SOAR-HP