A Study of Sintilimab Combined With Chemotherapy for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma

A Study of Sintilimab Combined With Chemotherapy for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma

This study is aimed to evaluate the efficacy and safety of sintilimab combined with chemotherapy (docetaxel+cisplatin+5-fluorouracil, DCF) in neoadjuvant treatment of locally advanced esophageal squamous cell carcinoma.

This study was designed as a single arm, phase II trial. Subjects will receive 3 cycles of Sintilimab combined with DCF as neoadjuvant therapy. The primary endpoint is pathologic complete response(pCR).

Inclusion Criteria:

• ≥18 years old and ≤75 years old
• Esophageal squamous cell carcinoma diagnosed biopsy histopathology
• The primary tumor is located in the middle of the esophagus and T1b-3N1-3M0 /M1 or T3N0M0 diagnosed by CT/MRI/EUS (AJCC 8th)
• 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