At a glance
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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
In Brief
A Phase 2 clinical trial evaluating Neoadjuvant immunochemotherapy, Surufatinib Administration, and 2 other interventions for Toripalimab and 4 related conditions. Currently recruiting, targeting 69 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.
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.
All patients will undergo thoracic intensity-modulated radiotherapy (IMRT), delivered once daily, 5 days per week, at a total prescribed dose of 50 Gy.