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

Plain Language Summary

Simplified for easier understanding

This study is testing a combination treatment for locally advanced esophageal squamous cell carcinoma (cancer of the food pipe) that cannot be surgically removed, combining chemotherapy, immunotherapy (tislelizumab), radiation therapy, and surufatinib (a drug that cuts off tumor blood supply). **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with esophageal squamous cell cancer confirmed by biopsy - Your cancer is locally advanced and cannot be surgically removed (T2 to T4, with or without limited lymph node involvement, no distant spread except possibly neck lymph nodes) - You have not received any prior cancer treatment (chemotherapy, radiation, surgery, or immunotherapy) - Your estimated survival is at least 12 weeks **You may NOT be eligible if...** - You have received any prior cancer treatments - You have active autoimmune disease - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.