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

Официальное название

Neoadjuvant Chemotherapy Combined With Finotonlimab in the Treatment of Locally Advanced Hypopharyngeal Carcinoma: A Multicenter Randomized Controlled Study

Обзор

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

Подробное описание

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%).

Вмешательства

• Препарат Finolizumab
  200mg every 3 weeks (q3w) for 2 cycles.
• Препарат Albumin-Bound Paclitaxel /nab-Paclitaxel
  260mg/m², day 1, every 3 weeks (q3w) for 2 cycles.
• Препарат Cisplatin
  25mg/m², days 1-3, every 3 weeks (q3w) for 2 cycles.
• Лучевая терапия Definitive radiotherapy
  Definitive radiotherapy (68-70Gy) with concurrent cisplatin-based chemotherapy (25mg/m², days 1-3, every 3 weeks)
• Процедура Surgery with postoperative radiotherapy or chemoradiotherapy.
  surgery with postoperative radiotherapy or chemoradiotherapy.

Первичные конечные точки

• Event-free survival (EFS) [Срок оценки: 2 years]

Вторичные конечные точки (5)

• Overall Survival (OS) [Срок оценки: 2 years]
• Locoregional Control Rate (LRFS) [Срок оценки: 2 years]
• Laryngeal Preservation Rate [Срок оценки: 2 years]
• Major Pathological Response Rate (MPR) [Срок оценки: 2 years]
• Adverse events [Срок оценки: 2 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 7 центров

• Harbin Medical University Cancer Hospital — Харбин
• Shandong Provincial ENT Hospital — Цзинань
• Beijing Tongren Hospital, Capital Medical University — Пекин
• Cancer Hospital Chinese Academy of Medical Sciences — Пекин
• Eye & ENT Hospital, Fudan University — Шанхай
• Zhongshan Hospital of Fudan University — Шанхай
• Tianjin Medical University Cancer Institute & Hospital — Тяньцзинь

Идентификаторы

NCT: NCT07248956 · SOAR-HP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗