Single-center randomized phase 2 trial of addition of sintilimab to total neoadjuvant therapy for locally advanced rectal cancer

The randomized phase 2 SPRING-01 trial at Shandong First Medical University (Jinan, China) evaluated addition of sintilimab to total neoadjuvant therapy consisting of short-course radiotherapy followed by capecitabine-oxaliplatin chemotherapy for locally advanced rectal cancer (LARC). Patients received short-course radiotherapy followed by sintilimab and capecitabine-oxaliplatin (sintilimab group) or short-course radiotherapy followed by capecitabine-oxaliplatin (control group), with TME surgery 2-3 weeks after completion of total neoadjuvant therapy. The pCR rate was 59.2% in the sintilimab group versus 32.7% in the control group (p=0.015). The safety profile in the sintilimab group was manageable. The authors conclude that sintilimab added to total neoadjuvant therapy for LARC might be a promising treatment approach for LARC.