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

Neoadjuvant Therapy for Locally Advanced Low Rectal Cancer (SMARTi-RC01) is a phase 2, randomised interventional study registered as NCT07134101 by The First Affiliated Hospital with Nanjing Medical University, with a registry enrolment figure of 138 participants, started 2025-09-01 and due to reach its primary completion in 2028-08-31. Interventions recorded: Serplulimab; Bevacizumab; Short-Course Radioterapy; Chemotherapy (CAPOX or capecitabine). Conditions listed: Colorectal Cancer (Diagnosis). Primary outcome: Complete Remission (CR) Rate assessed by pathology, MRI, endoscopy, and clinical examination. Colorectal eligibility wording from the registry: "Diagnosis: Pathologically confirmed rectal adenocarcinoma with proficient mismatch repair (pMMR) / microsatellite stable (MSS) status, based on biopsy of the primary tumor". No results are recorded here; the registry entry is the source.