A Prospective, Single-arm, Phase II Clinical Trial of Surufatinib in Combination With Neoadjuvant Chemo-immunotherapy and Concurrent Chemoradiotherapy for Patients With Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- 2-year progression-free survival rate
研究概览
简要总结
The combination of surufatinib with neoadjuvant chemo-immunotherapy and definitive concurrent chemoradiotherapy represents a promising new therapeutic strategy that may further improve the prognosis of patients with unresectable locally advanced esophageal squamous cell carcinoma (ESCC). Therefore, we propose to conduct a prospective, single-arm, phase II clinical trial to evaluate the efficacy and safety of this regimen in patients with unresectable, locally advanced ESCC.
详细描述
This is a prospective, single-arm, phase II clinical trial designed to evaluate the efficacy and safety of surufatinib in combination with neoadjuvant chemo-immunotherapy and concurrent chemoradiotherapy in patients with unresectable locally advanced esophageal squamous cell carcinoma. Patients will first receive two cycles of neoadjuvant therapy consisting of albumin-bound paclitaxel, cisplatin, toripalimab, and surufatinib. This will be followed by definitive concurrent chemoradiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed diagnosis of esophageal squamous cell carcinoma (ESCC).
- •Locally advanced, unresectable esophageal cancer assessed by endoscopic ultrasound and imaging studies, including esophagography, contrast-enhanced CT scans of the lower neck, chest, and upper abdomen, MRI of the lower neck and chest, whole-body bone scintigraphy, or PET/CT; staged as T2-4, N0-3, M0-1 (M1 limited to supraclavicular lymph node metastasis).
- •Male or female patients aged 18 to 80 years.
- •No prior chemotherapy, radiotherapy, surgery, targeted therapy, or immunotherapy.
- •Expected life expectancy of at least 12 weeks.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Adequate organ and bone marrow function defined as: Forced expiratory volume in one second (FEV1) ≥ 1000 mL; Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelet count ≥ 100 × 10⁹/L; Hemoglobin ≥ 90 g/L; Creatinine clearance ≥ 50 mL/min calculated by the Cockcroft-Gault formula (Cockcroft and Gault, 1976); Total bilirubin ≤ 1.5 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN.
- •Signed and dated informed consent form must be obtained prior to any study-related procedures.
排除标准
- •Participation in another clinical trial simultaneously, except for observational (non-interventional) studies.
- •Prior use of any targeted therapy.
- •Major surgery within 4 weeks prior to study entry (excluding vascular access procedures).
- •Uncontrolled comorbidities, including but not limited to active or ongoing infections, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, arrhythmias, active peptic ulcer disease or gastritis, intestinal perforation, bowel obstruction, active bleeding disorders, or psychiatric/social conditions that may impair compliance with study requirements or the ability to provide informed consent.
- •Performance status (PS) score of 2-
- •Presence of any of the following organ or bone marrow dysfunctions: Forced expiratory volume in one second (FEV1) < 1000 mL; Absolute neutrophil count (ANC) < 1.5 × 10⁹/L; Platelet count < 100 × 10⁹/L; Hemoglobin < 90 g/L; Creatinine clearance < 50 mL/min calculated by the Cockcroft-Gault formula (Cockcroft and Gault, 1976); Total bilirubin > 1.5 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2.5 × ULN.
- •Any condition that may interfere with the assessment of efficacy or safety of surufatinib.
研究组 & 干预措施
The study group
Patients will first receive two cycles of neoadjuvant therapy consisting of albumin-bound paclitaxel, cisplatin, toripalimab, and surufatinib. This will be followed by definitive concurrent radiotherapy combined with albumin-bound paclitaxel, cisplatin, toripalimab, and surufatinib.
干预措施: Neoadjuvant immunochemotherapy (Drug)
The study group
Patients will first receive two cycles of neoadjuvant therapy consisting of albumin-bound paclitaxel, cisplatin, toripalimab, and surufatinib. This will be followed by definitive concurrent radiotherapy combined with albumin-bound paclitaxel, cisplatin, toripalimab, and surufatinib.
干预措施: Surufatinib Administration (Drug)
The study group
Patients will first receive two cycles of neoadjuvant therapy consisting of albumin-bound paclitaxel, cisplatin, toripalimab, and surufatinib. This will be followed by definitive concurrent radiotherapy combined with albumin-bound paclitaxel, cisplatin, toripalimab, and surufatinib.
干预措施: Concurrent Chemotherapy (Drug)
The study group
Patients will first receive two cycles of neoadjuvant therapy consisting of albumin-bound paclitaxel, cisplatin, toripalimab, and surufatinib. This will be followed by definitive concurrent radiotherapy combined with albumin-bound paclitaxel, cisplatin, toripalimab, and surufatinib.
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
2-year progression-free survival rate
时间窗: 2 years
The 2-year progression-free survival rate refers to the proportion of patients who remain alive without evidence of disease progression at 24 months after initiation of treatment.
次要结局
- Median overall survival (OS)(2 years)
- Objective Response Rate (ORR)(2 months after CCRT)
- Locoregional Progression-Free Survival (LRPFS)(2 years)
- Distant Metastasis-Free Survival (DMFS)(2 years)
- Patient-reported quality of life(1 year after treatment)
- Treatment-related adverse events(1 year after treatment)
- Patient-reported esophageal-specific symptoms(1 year after treatment)
研究者
Hui Liu
Professor
Sun Yat-sen University