Phase II Study of Camrelizumab with Long-course Chemoradiotherapy for Total Neoadjuvant Treatment in Adults with Locally Advanced Low pMMRMSS Rectal Cancer

What this Trial Is About

Researchers are evaluating a new combined treatment approach for patients with locally advanced low pMMRMSS rectal cancer. This Phase II study aims to see if adding camrelizumab, an immunotherapy drug, to the standard long-course chemoradiotherapy LCRT can improve the rate of complete tumor response and potentially allow for organ preservation. This innovative treatment sequence involves chemo-immunotherapy both before and after radiation. Participants receive two cycles of camrelizumab combined with CAPOX chemotherapy, followed by long-course chemoradiotherapy consisting of a total radiation dose of 50.4 Gy given in 28 fractions along with concurrent oral capecitabine. Surgery is planned 4-6 weeks after the therapy, and pathological evaluation occurs within 1-2 weeks post-surgery. The study focuses on a single treatment group receiving this combination. During the study, doctors will assess complete response rates using imaging and endoscopy 4-6 weeks after therapy, and pathological response after surgery. Participants will undergo laboratory tests and clinical evaluations to monitor safety and treatment effects. The total participation lasts through neoadjuvant therapy and surgical assessment, aiming to improve treatment outcomes in this specific rectal cancer population.

A Single-arm Phase II Clinical Study of Camrelizumab Combined With Long-course Chemoradiotherapy for Total Neoadjuvant Therapy in Locally Advanced Low pMMR/MSS Rectal Cancer