Neoadjuvant Therapy for Locally Advanced Low Rectal Cancer (SMARTi-RC01)

The goal of this clinical trial is to learn if combining serplulimab (PD-1 inhibitor) with bevacizumab and short-course total neoadjuvant therapy (TNT) works to treat locally advanced mid-to-low rectal cancer in adults. It will also learn about the safety of this combination. The main questions it aims to answer are: Does adding bevacizumab to serplulimab and TNT increase the complete remission rate (cCR + pCR) compared with serplulimab and TNT alone? What medical problems do participants have when receiving these treatments? Researchers will compare: Experimental group: serplulimab + bevacizumab + chemotherapy + short-course radiotherapy Control group: serplulimab + chemotherapy + short-course radiotherapy Participants will: Receive either the experimental or control regimen for about 4-5 months before surgery or a watch-and-wait approach if complete response is achieved Undergo treatment in cycles that include chemotherapy, immunotherapy (and bevacizumab if in the experimental group), and short-course radiotherapy Visit the clinic regularly for check-ups, blood tests, imaging, endoscopy, and to monitor side effects Be followed for up to 5 years after treatment to assess cancer control, organ preservation, and survival outcomes

NCT Number	NCT07134101
Lead Sponsor	The First Affiliated Hospital with Nanjing Medical University
Conditions	Colorectal Cancer (Diagnosis)
Enrollment	138 participants
Start Date	2025-09-01
Primary Completion	2028-08-31 (estimated)
Study Completion	2030-08-31 (estimated)
Updated on ClinicalTrials.gov	2025-08-29