RecruitingPhase 2NCT07086469

Surufatinib in Combination With Neoadjuvant Chemo-immunotherapy and Concurrent Chemoradiotherapy for Patients With Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma

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

Sponsor

Sun Yat-sen University

Enrollment

69 participants

Start Date

Jul 20, 2025

Study Type

INTERVENTIONAL

Conditions

Esophageal Squamous Cell Carcinoma Chemoradiotherapy Toripalimab Surufatinib Neoadjuvant Immunochemotherapy

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria8

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 1.
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.

Exclusion Criteria7

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 2-4.
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.

Interventions

DRUGNeoadjuvant immunochemotherapy

Albumin-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.

DRUGSurufatinib Administration

Surufatinib 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.

DRUGConcurrent Chemotherapy

Toripalimab 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.

RADIATIONRadiotherapy

All patients will undergo thoracic intensity-modulated radiotherapy (IMRT), delivered once daily, 5 days per week, at a total prescribed dose of 50 Gy.