Squamous Cell Carcinoma of the Anal Canal

This is a single-arm, exploratory clinical study intended to enroll patients with EGFR-positive Locally Advanced Squamous Cell Carcinoma of the Anal Canal (T2-4N0-1M0). Patients will first receive 2 cycles of induction therapy consisting of Becotatug Vedotin combined with Pucotenlimab and Capecitabine. Patients without disease progression upon radiological assessment will subsequently proceed to the concurrent chemoradiotherapy-immunotherapy phase, which comprises Capecitabine plus Pucotenlimab and mitomycin-C together with definitive concurrent radiotherapy. In the subsequent maintenance phase, patients will receive Pucotenlimab for a total duration of 1 year. The study aims to evaluate the efficacy and safety of Becotatug Vedotin combined with Pucotenlimab and Capecitabine, as well as the potential of this novel full-course treatment paradigm.

This study examines care pathways in 300 patients with anal squamous cell carcinoma to identify barriers and delays in diagnosis, assess the impact of screening and access to care, and improve awareness, screening practices, and early diagnosis.

To provide retifanlimab, on a reactive basis, to adult patients with squamous carcinoma of the anal canal in combination with carboplatin and paclitaxel and who are considered ineligible for other therapeutic options including clinical trials.