Short-course Radiotherapy Combined With Sintilimab for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma

Short-course Radiotherapy Combined With Sintilimab for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma

This study is aimed to evaluate the efficacy and safety of short-course radiotherapy combined with sintilimab in neoadjuvant treatment of stage III, locally advanced esophageal squamous cell carcinoma.

This study was designed as a single arm, phase II trial. Subjects will receive short-course radiotherapy combined with sintilimab as neoadjuvant therapy of stage III, locally advanced esophageal squamous cell carcinoma. The primary endpoint is pathologic complete response(pCR).

Inclusion Criteria:

• 18 years old and ≤75 years old

  • Esophageal squamous cell carcinoma diagnosed biopsy histopathology
  • Patients with resectable esophageal squamous cell carcinoma confirmed by pathology (including histology or cytology) , with pathological stage T3-4 or N+
  • At least one measurable lesion
  • Eastern cooperative oncology group (ECOG) performance status of 0 to 1
  • With adequate organs function

Exclusion Criteria:

• Patients with active malignancy within 5 years other than the tumor studied in this study or a localized tumor that has been cured such as resected basal or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or breast cancer
• Patients who have a higher risk of bleeding or perforation due to the tumor's obvious invasion of the adjacent organs (aorta or trachea) of the esophageal lesion, or patients who have formed a fistula
• Patients who have received any anti-tumor therapy for the research disease in the past, including radiotherapy, chemotherapy, immunotherapy (including but not limited to interleukin, interferon, thymus hormone) and traditional Chinese medicine therapy