NCT07134101View on ClinicalTrials.gov

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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

138

Participants

Timeline

Start Date

September 1, 2025

Primary Completion Date

August 31, 2028

Study Completion Date

August 31, 2030

Conditions
Colorectal Cancer (Diagnosis)
Interventions
DRUG

Serplulimab

Serplulimab 300 mg IV on Day 1

DRUG

Bevacizumab

Bevacizumab 5 mg/kg IV on Day 1

RADIATION

Short-Course Radioterapy

25 Gy in 5 fractions over 1 week

DRUG

Chemotherapy (CAPOX or capecitabine)

Capecitabine: 800 mg/m² orally, twice daily (BID), on Days 1-14 of each cycle Oxaliplatin: 130 mg/m² intravenous infusion, on Day 1 of each cycle

All Listed Sponsors
lead

The First Affiliated Hospital with Nanjing Medical University

OTHER