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.
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.
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.
Single group
Neoadjuvant immunochemotherapy
DrugAlbumin-bound paclitaxel 260 mg/m² on day 1, cisplatin 25 mg/m² on days 1-3, and toripalimab 240 mg on day 1 of each 3-week cycle (q3w), for a total of 2 cycles.
Surufatinib Administration
DrugSurufatinib 200 mg orally once daily (po, qd) on days 1-14, administered concurrently with immunochemotherapy. During radiotherapy, surufatinib will be administered at the start of each radiotherapy phase.
Concurrent Chemotherapy
DrugToripalimab 240 mg on day 1 of each 3-week cycle (q3w), starting one day prior to the initiation of radiotherapy. Weekly administration of albumin-bound paclitaxel 50 mg/m² and cisplatin 25 mg/m² on day 1 during the radiotherapy course.
Radiotherapy
RadiationAll patients will undergo thoracic intensity-modulated radiotherapy (IMRT), delivered once daily, 5 days per week, at a total prescribed dose of 50 Gy.
2-year progression-free survival rate
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.
Median overall survival (OS)
The time from the start of treatment to death from any cause.
Objective Response Rate (ORR)
The objective response rate refers to the proportion of patients with a measurable reduction in tumor burden, including complete response (CR) and partial response (PR), as defined by standardized criteria such as RECIST (Response Evaluation Criteria in Solid Tumors).
Locoregional Progression-Free Survival (LRPFS)
LRPFS is defined as the time from the start of treatment to the first occurrence of locoregional disease progression or death from any cause.
Distant Metastasis-Free Survival (DMFS)
DMFS refers to the time from treatment initiation to the first occurrence of distant metastasis or death from any cause. It reflects the effectiveness of systemic disease control.
Click on the lead sponsor to view all of their trials.
