Adebrelimab Injection with Short Course Radiotherapy and CAPOX Chemotherapy as Preoperative Treatment for Locally Advanced Rectal Cancer A Multicenter Phase 2 Study

What this Trial Is About

Researchers are evaluating the safety and effectiveness of combining adebelimab with short course radiotherapy and CAPOX chemotherapy as a preoperative treatment for patients with locally advanced rectal cancer. This multicenter, single arm, prospective Phase 2 study focuses on patients with tumors meeting specific staging and operability criteria who have not received prior anti-tumor treatments. The goal is to assess how well this combination works before surgery and its safety profile. Participants will receive short course radiotherapy 5 sessions of 5 Gy each, followed by adebelimab injections given intravenously at a dose of 1200 mg or 20 mgkg on the first day of each chemotherapy cycle. Chemotherapy includes oxaliplatin and capecitabine administered over six 3-week cycles. After completing chemotherapy, participants will undergo total mesorectal excision TME surgery 2 to 3 weeks later. If surgery is delayed due to adverse reactions or other reasons, researchers will adjust based on the patients condition. Throughout the study, participants will be monitored with imaging and colonoscopy exams to evaluate tumor response. Laboratory tests will assess organ function and safety. The primary outcome is the pathological complete remission rate measured from enrollment through surgery over about six months. Secondary outcomes include tumor response rates, surgical success, and adverse reaction rates. Study visits, assessments, and safety monitoring will continue through surgery and up to 90 days after final treatment, with total participation lasting several months.

Adebrelimab Injection (PD-L1) Combined With Short Course Radiotherapy and Chemotherapy for Neoadjuvant Therapy of Locally Advanced Rectal Cancer