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Phase 3
Age: 18Years - 75Years
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ID07454720

Study of Adebrelimab with SHR-8068 and Chemoradiotherapy as Perioperative Treatment for Locally Advanced Rectal Cancer Phase IIIII Randomized Clinical Trial

Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2026-05-05

165

Participants Needed

2

Research Sites

156 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of combining Adebrelimab and SHR-8068 with chemoradiotherapy as a perioperative treatment for patients with locally advanced rectal cancer that can be surgically removed. This phase IIIII clinical trial aims to improve outcomes for this condition by comparing different treatment combinations. The study is sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd. and involves multiple centers with randomized group assignments. Participants will be assigned to one of three treatment groups one receiving radiotherapy combined with Adebrelimab, SHR-8068, and chemotherapy another receiving radiotherapy with Adebrelimab and chemotherapy and a third receiving radiotherapy plus chemotherapy alone. These treatments are given around the time of surgery to assess their impact on the cancer. Dosing and specific schedules are managed as part of the clinical protocol. During the study, participants will undergo evaluations including pathological complete response rates at 12 months and additional measures such as clinical complete response, disease-free survival, event-free survival, tumor regression grade, surgical outcomes, hospital stay length, overall survival, and perioperative mortality over 60 months. Researchers will monitor safety, treatment effects, and surgical outcomes through regular assessments. The total study duration extends until November 2035, allowing for long-term follow-up of participants.

CONDITIONS

Brief Title

A Clinical Study of Adebrelimab in Combination With SHR-8068 and Chemoradiotherapy as Perioperative Therapy for Locally Advanced Rectal Cancer

Research Team

C

Chuanpei Huang

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