Neoadjuvant Chemotherapy Combined With Finotonlimab in the Treatment of Locally Advanced Hypopharyngeal Carcinoma: A Multicenter Randomized Controlled Study
概览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 116
- 试验地点
- 7
- 主要终点
- Event-free survival (EFS)
概览
简要总结
This is a multi-center, randomized controlled, prospective clinical study.
详细描述
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%).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
neoadjuvant therapy followed by surgery and (C)RT group
Patients initially receive immunotherapy with Finolizumab and chemotherapy with albumin-bound paclitaxel and cisplatin. Patients with response of complete reaction (CR)/partial reaction (PR)≥50% after neoadjuvant chemotherapy then receive surgery, followed by postoperative radiotherapy or chemoradiotherapy.
干预措施: Finolizumab (Drug)
neoadjuvant therapy followed by surgery and (C)RT group
Patients initially receive immunotherapy with Finolizumab and chemotherapy with albumin-bound paclitaxel and cisplatin. Patients with response of complete reaction (CR)/partial reaction (PR)≥50% after neoadjuvant chemotherapy then receive surgery, followed by postoperative radiotherapy or chemoradiotherapy.
干预措施: Albumin-Bound Paclitaxel /nab-Paclitaxel (Drug)
neoadjuvant therapy followed by surgery and (C)RT group
Patients initially receive immunotherapy with Finolizumab and chemotherapy with albumin-bound paclitaxel and cisplatin. Patients with response of complete reaction (CR)/partial reaction (PR)≥50% after neoadjuvant chemotherapy then receive surgery, followed by postoperative radiotherapy or chemoradiotherapy.
干预措施: Cisplatin (Drug)
neoadjuvant therapy followed by surgery and (C)RT group
Patients initially receive immunotherapy with Finolizumab and chemotherapy with albumin-bound paclitaxel and cisplatin. Patients with response of complete reaction (CR)/partial reaction (PR)≥50% after neoadjuvant chemotherapy then receive surgery, followed by postoperative radiotherapy or chemoradiotherapy.
干预措施: Surgery with postoperative radiotherapy or chemoradiotherapy. (Procedure)
neoadjuvant therapy followed by CCRT group
Patients initially receive immunotherapy with Finolizumab and chemotherapy with albumin-bound paclitaxel and cisplatin. Patients with response of complete reaction (CR)/partial reaction (PR)≥50% after neoadjuvant chemotherapy then receive definitive radiotherapy with concurrent cisplatin-based chemotherapy.
干预措施: Finolizumab (Drug)
neoadjuvant therapy followed by CCRT group
Patients initially receive immunotherapy with Finolizumab and chemotherapy with albumin-bound paclitaxel and cisplatin. Patients with response of complete reaction (CR)/partial reaction (PR)≥50% after neoadjuvant chemotherapy then receive definitive radiotherapy with concurrent cisplatin-based chemotherapy.
干预措施: Albumin-Bound Paclitaxel /nab-Paclitaxel (Drug)
neoadjuvant therapy followed by CCRT group
Patients initially receive immunotherapy with Finolizumab and chemotherapy with albumin-bound paclitaxel and cisplatin. Patients with response of complete reaction (CR)/partial reaction (PR)≥50% after neoadjuvant chemotherapy then receive definitive radiotherapy with concurrent cisplatin-based chemotherapy.
干预措施: Cisplatin (Drug)
neoadjuvant therapy followed by CCRT group
Patients initially receive immunotherapy with Finolizumab and chemotherapy with albumin-bound paclitaxel and cisplatin. Patients with response of complete reaction (CR)/partial reaction (PR)≥50% after neoadjuvant chemotherapy then receive definitive radiotherapy with concurrent cisplatin-based chemotherapy.
干预措施: Definitive radiotherapy (Radiation)
结局指标
主要结局
Event-free survival (EFS)
时间窗: 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.
次要结局
- Overall Survival (OS)(2 years)
- Locoregional Control Rate (LRFS)(2 years)
- Laryngeal Preservation Rate(2 years)
- Major Pathological Response Rate (MPR)(2 years)
- Adverse events(2 years)
研究者
Ming Zhang
Principal Investigator
Eye & ENT Hospital of Fudan University