Intestinal Low-Dose Radiotherapy Combined with Immunochemotherapy Before Surgery for Borderline Resectable or Unresectable Esophageal Squamous Cell Carcinoma

What this Trial Is About

Esophageal squamous cell carcinoma ESCC is a common and deadly form of esophageal cancer, especially in China where more than half of global cases occur. Locally advanced cases that cannot be surgically removed have high recurrence and low survival rates. Research shows that comprehensive treatment followed by surgery can improve survival and quality of life. This trial investigates combining intestinal low-dose radiotherapy with immunochemotherapy as a conversion therapy for patients with borderline resectable or unresectable thoracic ESCC. Participants will receive a single fraction of 1 Gy intestinal low-dose radiotherapy targeting the jejunum and ileum. Concurrently, they will undergo three cycles of albumin-bound paclitaxel 260 mgm on day 1, cisplatin 75 mgm on day 1, and tislelizumab 200 mg on day 1. After this combined conversion therapy, surgery such as McKeown esophagectomy is recommended. The study is designed as a phase II single-arm trial enrolling at least 39 evaluable patients in two stages. During the trial, researchers will evaluate treatment safety and effectiveness, including pathological complete response rates up to 15 weeks after surgery. Other outcomes include major pathological response, objective response, disease control, adverse events, survival rates, surgical conversion, and R0 resection rates. Follow-up assessments occur regularly for up to 12 months post-surgery to monitor disease status and safety. Participants will undergo laboratory tests and imaging as required to track their progress throughout the study.

Intestinal Low-Dose Radiotherapy Plus Immunochemotherapy for Conversion of Borderline Resectable/Unresectable Esophageal Squamous Cell Carcinoma